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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 26

Secondary 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

Page last updated: August 20, 2015

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