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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00839306

First received: February 5, 2009

Last updated: May 9, 2013

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 5, 2009

Last Updated Date

May 9, 2013

Start Date ^ICMJE

August 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome measure will include: esophagogastroduodenoscopy (EGD), Investigator's assessment of symptoms, quality of life as recorded by subjects and concomitant use of dispensed antacid. [ Time Frame: Week 13 and week 26. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00839306 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary outcome measures will include: adverse events, electrocardiograms (ECGs), laboratory evaluations (hematology, blood chemistry, urinalysis, gastrin), gastric biopsies, physical exam and vital signs. [ Time Frame: Week 13 and week 26. ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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).

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, 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Gastroesophageal Reflux Disease (GERD)

Intervention ^ICMJE

Drug: Rabeprazole ER
50 mg capsule, taken orally, once daily for 26 weeks.

Other Name: Aciphex
Drug: Ranitidine
150 mg capsule, taken orally, twice daily for 26 weeks.

Study Arm (s)

Experimental: 1
Intervention: Drug: Rabeprazole ER
Active Comparator: 2
Intervention: Drug: Ranitidine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

January 2010

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

KEY INCLUSION CRITERIA:

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

KEY EXCLUSION CRITERIA:

Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).
Barrett's esophagus or esophageal stricture.
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.
Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (≥ 20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day).
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.
Any condition that would make the subject, in the opinion of the Investigator or Sponsor, unsuitable for the study.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00839306

Other Study ID Numbers ^ICMJE

E3810-G000-306, EudraCT No. 2007-007733-39

Has Data Monitoring Committee

Not Provided

Responsible Party

Eisai Inc.

Study Sponsor ^ICMJE

Eisai Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Guillermo Rossiter, M.D.

Eisai Inc.

Information Provided By

Eisai Inc.

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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