Status:
COMPLETED
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
Eisai Inc.
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 w...
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...
Eligibility Criteria
Inclusion
- 1\. 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
- 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.
Key Trial Info
Start Date :
August 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2009
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00838526
Start Date
August 31 2008
End Date
December 31 2009
Last Update
April 25 2022
Active Locations (4)
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1
Ltd.
Moline, Illinois, United States, 61265
2
Midwest Clinical
Moline, Illinois, United States, 61265
3
Research Associates
Moline, Illinois, United States, 61265
4
Moline, Illinois, United States, 61265