Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)



Status:Completed
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:August 2008
End Date:December 2009

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Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

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).

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).

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.
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Moline, Illinois 61265
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Moline, IL
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Moline, Illinois 61265
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from
Moline, IL
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