Phase 3
N=235
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux Disease (GERD)
Bottom Line
View on ClinicalTrials.gov: NCT00838526 ↗Enrolled (actual)
235
Serious AEs
4.7%
Results posted
Jun 2015
Primary outcome: Primary: Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26 — 32.9; 84.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rabeprazole ER (Drug); Ranitidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26 |
32.9; 84.9 | — |
| SECONDARY Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26 |
8.5; 57.4; 25.4; 18.8; 66.1; 23.9 | — |
| SECONDARY Percentage of Participants With Adverse Events by Category |
47.5; 64.2; 8.5; 14.5; 3.4; 8.1 | — |
Summary
The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 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).
Eligibility Criteria
Inclusion Criteria
- Prior completion of Study E3810-G000-301 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-G000-301 or -303.
Exclusion Criteria
- Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).
- Barrett's esophagus or esophageal stricture.
- Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs with significant anticholinergic effects throughout the study.
- Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).
- Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would be likely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study.
- Any condition that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study.
Data sourced from ClinicalTrials.gov (NCT00838526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.