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

Last updated: January 11, 2016
Sponsor: Eisai Inc.
Overall Status: Completed

Phase

3

Condition

Heartburn (Pediatric)

Non-ulcer Dyspepsia (Nud)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT00839306
E3810-G000-306
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to compare the efficacy of rabeprazole extended release 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

KEY INCLUSION CRITERIA:

  1. Prior completion of Study E3810-G000-302 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-G000-302 or -303.

Exclusion

KEY 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 01, 2008
Estimated Completion Date:
January 31, 2010

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, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily).

Please note that this study is not a duplicate of E3810-G000-305; this is a separate study being conducted along with -305.

Connect with a study center

  • Associates, Ltd.

    Moline, Illinois 61265
    United States

    Site Not Available

  • Midwest Clinical

    Moline, Illinois 61265
    United States

    Site Not Available

  • Research

    Moline, Illinois 61265
    United States

    Site Not Available

  • Moline, Illinois 61265
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.