A Phase 3 interventional study of Lansoprazole and Gefarnate in Stomach Ulcer and Duodenal Ulcer, sponsored by Takeda. Completed at 68 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-02-03.
Sponsored by Takeda · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).
In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of death.
The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily nonsteroid anti-inflammatory medication.
75 studies on the registry are indexed under Duodenal Ulcer; 5 are open to participants now.
This study's enrollment of 366 is above the median of 284 across 50 interventional studies indexed under Duodenal Ulcer.
Browse Duodenal Ulcer studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Lansoprazole
Drug: Gefarnate
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Also known as: AG-1749
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time frame: 24 Months
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 3.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 6.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 12.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 18.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 24.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 3.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 6.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 12.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 18.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 24.
Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time frame: On occurrence (up to month 24).
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)
The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)
The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)
The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.
Time frame: Per Incidence (up to 24 months).
Participants were enrolled at sites in Japan from April 2007 to May 2009.
| Milestone | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Started | 185 | 181 |
| Completed | 109 | 99 |
| Not completed | 76 | 82 |
| Withdrew: Adverse event | 24 | 23 |
| Withdrew: Protocol violation | 26 | 23 |
| Withdrew: Withdrawal by subject | 16 | 11 |
| Withdrew: Lack of efficacy | 4 | 15 |
| Withdrew: Nsaids discontinuation | 1 | 2 |
| Withdrew: Institution closed | 1 | 0 |
| Withdrew: Physician decision | 4 | 8 |
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
| participants | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | 15 | 46 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | -0.114 ± 1.020 | 0.429 ± 1.318 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | -0.319 ± 1.060 | 0.188 ± 1.268 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | -0.231 ± 1.299 | 0.048 ± 1.137 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) | -0.162 ± 1.280 | -0.278 ± 1.227 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) | -0.800 ± 1.304 | NA ± NA |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | -0.102 ± 0.499 | 0.142 ± 0.649 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | -0.095 ± 0.527 | 0.047 ± 0.373 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | -0.177 ± 0.675 | 0.048 ± 0.381 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) | -0.297 ± 0.812 | -0.056 ± 0.539 |
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) | -0.200 ± 0.447 | NA ± NA |
Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
| participants | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) | 15 | 52 |
The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) | -0.006 ± 0.178 | 0.014 ± 0.319 |
The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) | 0.027 ± 0.285 | 0.000 ± 0.347 |
The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) | -0.014 ± 0.208 | -0.020 ± 0.249 |
The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) | 0.000 ± 0.000 | 0.000 ± 0.000 |
The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24) | NA ± NA | — |
The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) | -0.044 ± 0.326 | 0.014 ± 0.400 |
The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) | 0.009 ± 0.393 | -0.036 ± 0.424 |
The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) | -0.029 ± 0.416 | -0.061 ± 0.317 |
The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) | 0.000 ± 0.000 | 0.000 ± 0.447 |
The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24) | NA ± NA | — |
The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) | -0.025 ± 0.318 | -0.014 ± 0.452 |
The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) | 0.000 ± 0.381 | -0.048 ± 0.408 |
The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) | -0.057 ± 0.336 | -0.204 ± 0.407 |
The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) | -0.056 ± 0.416 | 0.000 ± 0.447 |
The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24) | NA ± NA | — |
The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) | -0.006 ± 0.239 | 0.007 ± 0.308 |
The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) | 0.009 ± 0.286 | -0.012 ± 0.245 |
The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) | -0.043 ± 0.204 | -0.041 ± 0.200 |
The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) | 0.000 ± 0.000 | -0.091 ± 0.302 |
The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24) | NA ± NA | — |
The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) | -0.057 ± 0.378 | 0.058 ± 0.625 |
The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) | -0.027 ± 0.476 | -0.095 ± 0.428 |
The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) | -0.114 ± 0.363 | -0.102 ± 0.510 |
The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) | -0.056 ± 0.236 | 0.091 ± 0.302 |
The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24) | -1.000 ± NA | — |
The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) | 0.006 ± 0.138 | 0.022 ± 0.283 |
The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) | 0.036 ± 0.187 | 0.024 ± 0.268 |
The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) | 0.014 ± 0.208 | -0.020 ± 0.143 |
The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) | 0.056 ± 0.236 | 0.000 ± 0.000 |
The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24) | NA ± NA | — |
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3) | 0.006 ± 0.080 | -0.007 ± 0.085 |
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6) | 0.000 ± 0.000 | 0.012 ± 0.109 |
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12) | 0.043 ± 0.359 | 0.000 ± 0.000 |
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) | 0.000 ± 0.000 | 0.000 ± 0.000 |
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
| scores on a scale | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24) | NA ± NA | — |
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.
| participants | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| Adverse Event | 154 | 125 |
| Adverse event (Frequency ≥5%) | 83 | 64 |
| Adverse event related to the study drug | 28 | 28 |
| Serious adverse event | 29 | 17 |
| Serious adverse event related to the study drug | 2 | 1 |
Collected over Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication, and up to 24 months after the permanent discontinuation of the double-blind study medication.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lansoprazole 15 mg QD | — | 29/183 (15.8%) | 83/183 (45.4%) |
| Gefarnate 50 mg BID | — | 17/181 (9.4%) | 64/181 (35.4%) |
| Event | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| FallInjury, poisoning and procedural complications | 4/183 | 1/181 |
| Colonic polypGastrointestinal disorders | 3/183 | 0/181 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/183 | 0/181 |
| Inguinal herniaGastrointestinal disorders | 1/183 | 2/181 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 0/183 | 2/181 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 0/183 | 2/181 |
| PneumoniaInfections and infestations | 2/183 | 0/181 |
| Gastric ulcerGastrointestinal disorders | 0/183 | 1/181 |
| EnterocolitisGastrointestinal disorders | 0/183 | 1/181 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/183 | 1/181 |
| Event | Lansoprazole 15 mg QD | Gefarnate 50 mg BID |
|---|---|---|
| NasopharyngitisInfections and infestations | 51/183 | 37/181 |
| DiarrheaGastrointestinal disorders | 19/183 | 5/181 |
| Reflux esophagitisGastrointestinal disorders | 4/183 | 12/181 |
| FallInjury, poisoning and procedural complications | 12/183 | 10/181 |
| ConstipationGastrointestinal disorders | 10/183 | 10/181 |
| EczemaSkin and subcutaneous tissue disorders | 10/183 | 5/181 |
| Age, Customized(participants) | Lansoprazole 15 mg QD | Gefarnate 50 mg BID | Total |
|---|---|---|---|
| ≤39 years | 7 ± 3.8 | 6 ± 3.3 | 13 ± 3.6 |
| Between 40 and 49 years | 18 ± 9.7 | 13 ± 7.2 | 31 ± 8.5 |
| Between 50 and 59 years | 38 ± 20.5 | 43 ± 23.8 | 81 ± 22.1 |
| Between 60 and 64 years | 33 ± 17.8 | 29 ± 16.0 | 62 ± 16.9 |
| Between 65 and 69 years | 33 ± 17.8 | 30 ± 16.6 | 63 ± 17.2 |
| Between 70 and 79 years | 43 ± 23.2 | 48 ± 26.5 | 91 ± 24.9 |
| ≤80 years | 13 ± 7.0 | 12 ± 6.6 | 25 ± 6.8 |
| Sex: Female, Male(Participants) | Lansoprazole 15 mg QD | Gefarnate 50 mg BID | Total |
|---|---|---|---|
| Female | 112 | 107 | 219 |
| Male | 73 | 74 | 147 |
| Region of Enrollment(participants) | Lansoprazole 15 mg QD | Gefarnate 50 mg BID | Total |
|---|---|---|---|
| Japan | 185 | 181 | 366 |
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