Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Overview
- Phase
- Phase 3
- Intervention
- Rabeprazole ER
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Sponsor
- Eisai Inc.
- Enrollment
- 240
- Locations
- 3
- Primary Endpoint
- Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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).
Detailed Description
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, RAB ER 50 mg (once daily) or Ranitidine 150 mg (twice daily).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Prior completion of Study E3810-G000-301 or -
- •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.
Arms & Interventions
1
Intervention: Rabeprazole ER
2
Intervention: Ranitidine
Outcomes
Primary Outcomes
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
Time Frame: Baseline to 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 esophageal 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.
Secondary Outcomes
- Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26(Baseline to Week 26)
- Percentage of Participants With Adverse Events by Category(From the time of administration of the first dose of study drug up to a maximum of approximately 30 weeks.)