Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)
Intervention: Rabeprazole ER (Drug); Ranitidine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eisai Inc. Official(s) and/or principal investigator(s): Guillermo Rossiter, MD, Study Director, Affiliation: Eisai Inc.
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).
Clinical Details
Official title: Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
Secondary outcome: Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26Secondary Outcome Measures Will Include: Adverse Events, Electrocardiograms (ECGs), Laboratory Evaluations (Hematology, Blood Chemistry, Urinalysis, and Gastrin), Gastric Biopsies, Physical Exam, and Vital Signs.
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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 Criteria:
1. Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).
2. Barrett's esophagus or esophageal stricture.
3. 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.
4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs),
oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).
5. 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.
6. Any condition that would make the subject, in the opinion of the investigator or
sponsor, unsuitable for the study.
Locations and Contacts
Moline, Illinois 61265, United States
Ltd., Moline, Illinois 61265, United States
Midwest Clinical, Moline, Illinois 61265, United States
Research Associates, Moline, Illinois 61265, United States
Additional Information
Starting date: August 2008
Last updated: June 8, 2015
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