A Phase 3 interventional study of Rabeprazole ER and Ranitidine in Gastroesophageal Reflux Disease (GERD), sponsored by Eisai Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-08.
Sponsored by Eisai Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD).
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily).
Please note that this study is not a duplicate of E3810-G000-305; this is a separate study being conducted along with -305.
1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.
This study's enrollment of 240 is above the median of 72 across 724 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
KEY INCLUSION CRITERIA:
1. Prior completion of Study E3810-G000-302 or -303. Subjects will need to have healed erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and sustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-302 or -303.
KEY EXCLUSION CRITERIA:
Drug: Rabeprazole ER
Drug: Ranitidine
50 mg capsule, taken orally, once daily for 26 weeks.
Also known as: Aciphex
150 mg capsule, taken orally, twice daily for 26 weeks.
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.
Time frame: Baseline to Week 26
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).
Time frame: Baseline to Week 26
Participants were eligible for this study if they had completed one of the healing studies (E3810-G000-302 or E3810-G000-303), had no evidence of oesophageal erosions, had sustained heartburn resolution, and had no record of any serious adverse event (SAE) related to study medication during the healing study.
| Milestone | RAN 150mg BID | RAB ER 50mg QD |
|---|---|---|
| Started | 60 | 177 |
| Completed | 35 | 134 |
| Not completed | 25 | 43 |
| Withdrew: Adverse event | 3 | 5 |
| Withdrew: Lost to follow-up | 6 | 9 |
| Withdrew: Withdrawal by subject | 5 | 7 |
| Withdrew: Lack of efficacy | 5 | 4 |
| Withdrew: Other | 6 | 18 |
Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).
| Percentage of Participants | RAN 150mg BID | RAB ER 50mg QD |
|---|---|---|
| Yes | 8.3 | 53.7 |
| No | 16.7 | 17.5 |
| Missing | 75 | 28.8 |
eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.
| Percentage of Participants | RAN 150mg BID | RAB ER 50mg QD |
|---|---|---|
| Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26 | 31.7 | 88.4 |
Collected over For each participant, from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug or up to resolution of adverse event or up to approximately 30 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RAN 150mg BID | — | 1/56 (1.8%) | 22/56 (39.3%) |
| RAB ER 50mg QD | — | 3/170 (1.8%) | 42/170 (24.7%) |
| Event | RAN 150mg BID | RAB ER 50mg QD |
|---|---|---|
| PancreatitisGastrointestinal disorders | 1/56 | 0/170 |
| Chest painGeneral disorders | 0/56 | 1/170 |
| GastroenteritisInfections and infestations | 0/56 | 1/170 |
| PneumoniaInfections and infestations | 0/56 | 1/170 |
| DehydrationMetabolism and nutrition disorders | 0/56 | 1/170 |
| Event | RAN 150mg BID | RAB ER 50mg QD |
|---|---|---|
| Hiatus herniaGastrointestinal disorders | 6/56 | 7/170 |
| GastritisGastrointestinal disorders | 4/56 | 17/170 |
| Erosive oesophagitisGastrointestinal disorders | 5/56 | 2/170 |
| SinusitisInfections and infestations | 1/56 | 10/170 |
| DyspepsiaGastrointestinal disorders | 3/56 | 4/170 |
| Acquired oesophageal webGastrointestinal disorders | 3/56 | 2/170 |
| Age, Customized(Years) | RAN 150mg BID | RAB ER 50mg QD | Total |
|---|---|---|---|
| Mean | 47.5 ± 13.55 | 47.5 ± 12.06 | 47.5 ± 12.43 |
| Sex: Female, Male(Participants) | RAN 150mg BID | RAB ER 50mg QD | Total |
|---|---|---|---|
| Female | 28 | 88 | 116 |
| Male | 32 | 89 | 121 |
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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Studies of the drug tested here: Rabeprazole