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

Last updated: March 28, 2022
Sponsor: Eisai Inc.
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Gastroparesis

Non-ulcer Dyspepsia (Nud)

Treatment

N/A

Clinical Study ID

NCT00838526
E3810-G000-305
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Prior completion of Study E3810-G000-301 or -303. Subjects will need to have healederosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD andsustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-301 or -303.

Exclusion

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), histaminereceptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugswith 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 interferewith the conduct of the study, the interpretation of study results, or the health ofthe subject during the study.
  6. Any condition that would make the subject, in the opinion of the investigator orsponsor, unsuitable for the study.

Study Design

Total Participants: 240
Study Start date:
August 31, 2008
Estimated Completion Date:
December 31, 2009

Study 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).

Connect with a study center

  • Ltd.

    Moline, Illinois 61265
    United States

    Site Not Available

  • Midwest Clinical

    Moline, Illinois 61265
    United States

    Site Not Available

  • Research Associates

    Moline, Illinois 61265
    United States

    Site Not Available

  • Moline, Illinois 61265
    United States

    Site Not Available

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