An observational study in Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions, sponsored by Takeda. Completed. Per ClinicalTrials.gov, last updated 2016-02-23.
Sponsored by Takeda · Observational
The purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg) to a large number of patients in daily medical practice.
This survey was designed to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 mg (Takepron Intravenous 30 mg) to a large number of participants in daily medical practice.
For adults, 30 mg of lansoprazole is typically mixed in physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.
196 studies on the registry are indexed under Gastritis; 42 are open to participants now.
This study's enrollment of 1,120 is above the median of 400 across 79 observational studies indexed under Gastritis.
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Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesions
Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesion (all of which should be accompanied by bleeding).
Exclusion Criteria:
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Thirty milligrams of lansoprazole is mixed in physiological saline (JP) or 5 percent (%) glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 milliliter (mL) of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.
Drug: Lansoprazole
Lansoprazole intravenous 30 mg
Also known as: Takepron Intravenous 30 mg
Number of Participants Reporting One or More Adverse Drug Reactions
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Time frame: Baseline up to Week 9
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline up to Week 9
Percentage of Participants With Observed Hemostatic Effect
Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.
Time frame: Baseline up to Week 9
Percentage of Participants With Confirmed Hemostatic Effect
Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.
Time frame: Baseline up to Week 9
Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect
Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.
Time frame: Baseline up to Week 9
Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect
Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.
Time frame: Baseline up to Week 9
Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.
Time frame: Week 8 after the last dose of study drug (Week 17)
Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.
Time frame: Week 8 after the last dose of study drug (Week 17)
Participants took part in the study at 173 investigative site in Japan from 29 January 2007 to 31 March 2010.
| Milestone | Lansoprazole |
|---|---|
| Started | 1120 |
| Completed | 1084 |
| Not completed | 36 |
| Withdrew: Unavailability of case report form | 26 |
| Withdrew: Outside the contract period | 1 |
| Withdrew: Randomized, not treated | 1 |
| Withdrew: Unavailability of information | 8 |
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
| participants | Lansoprazole |
|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | 35 |
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
| participants | Lansoprazole |
|---|---|
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | 9 |
Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.
| percentage of participants | Lansoprazole |
|---|---|
| Percentage of Participants With Observed Hemostatic Effect | 90.3 |
Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.
| percentage of participants | Lansoprazole |
|---|---|
| Percentage of Participants With Confirmed Hemostatic Effect | 91.6 |
Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.
| percentage of participants | Lansoprazole |
|---|---|
| Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect | 1.1 |
Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.
| percentage of participants | Lansoprazole |
|---|---|
| Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect | 1.2 |
Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.
| percentage of participants | Lansoprazole |
|---|---|
| Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment | 5.8 |
Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.
| percentage of participants | Lansoprazole |
|---|---|
| Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment | 7.1 |
Collected over Baseline up to Week 17. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lansoprazole | — | 9/1,084 (0.8%) | 35/1,084 (3.2%) |
| Event | Lansoprazole |
|---|---|
| Gastric HaemorrhageGastrointestinal disorders | 4/1084 |
| InsomniaPsychiatric disorders | 1/1084 |
| RestlessnessPsychiatric disorders | 1/1084 |
| Depressive SymptomPsychiatric disorders | 1/1084 |
| Depressed level of consciousnessNervous system disorders | 1/1084 |
| DiarrhoeaGastrointestinal disorders | 1/1084 |
| Gastric Ulcer HaemorrhageGastrointestinal disorders | 1/1084 |
| CholangitisHepatobiliary disorders | 1/1084 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/1084 |
| White blood cell count decreasedInvestigations | 1/1084 |
| Event | Lansoprazole |
|---|---|
| Gastric haemorrhageGastrointestinal disorders | 7/1084 |
| DiarrhoeaGastrointestinal disorders | 3/1084 |
| Hepatic function abnormalHepatobiliary disorders | 3/1084 |
| Liver disorderHepatobiliary disorders | 3/1084 |
| PyrexiaGeneral disorders | 3/1084 |
| White blood cell count decreasedInvestigations | 3/1084 |
| InsomniaPsychiatric disorders | 2/1084 |
| RashSkin and subcutaneous tissue disorders | 2/1084 |
| Urinary tract infectionInfections and infestations | 1/1084 |
| AnaemiaBlood and lymphatic system disorders | 1/1084 |
The safety analysis set was defined as all participants who were enrolled and completed the study.
| Age, Continuous(years) | Lansoprazole |
|---|---|
| Mean | 66.2 ± 14.74 |
| Sex: Female, Male(Participants) | Lansoprazole |
|---|---|
| Female | 350 |
| Male | 734 |
| Pregnancy Status(participants) | Lansoprazole |
|---|---|
| Not Pregnant | 349 |
| Pregnant | 0 |
| Unknown | 1 |
| Target Diseases(participants) | Lansoprazole |
|---|---|
| Gastric Ulcer | 768 |
| Duodenal Ulcer | 221 |
| Gastroduodenal Ulcer | 23 |
| Acute Stress-Induced Ulcer | 8 |
| Acute Gastric Mucosal Lesion | 60 |
| Not Provided | 4 |
| Categories of Healthcare(participants) | Lansoprazole |
|---|---|
| Outpatient | 11 |
| Inpatient | 1073 |
| Predisposition to Hypersensitivity(participants) | Lansoprazole |
|---|---|
| No | 1042 |
| Yes | 39 |
| Unknown | 3 |
| Helicobacter pylori Infection(participants) | Lansoprazole |
|---|---|
| Negative | 199 |
| Positive | 434 |
| Unknown | 451 |
| Alcohol Consumption(participants) | Lansoprazole |
|---|---|
| Alcohol Consumer | 382 |
| Alcohol Non-Consumer | 547 |
| Unknown | 155 |
8 further baseline measures are reported on the registry.
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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