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

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00839306

Purpose

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).

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: Rabeprazole ER Drug: Ranitidine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Ranitidine Ranitidine Hydrochloride E 3810 Ranitidine bismuth citrate

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	240
Study Start Date:	August 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Rabeprazole ER 50 mg capsule, taken orally, once daily for 26 weeks.
2: Active Comparator	Drug: Ranitidine 150 mg capsule, taken orally, twice daily for 26 weeks.

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).

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839306

Locations

United States, Illinois
Midwest Clinical Research Associates, Ltd.
Moline, Illinois, United States, 61265

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Guillermo Rossiter, M.D.

Eisai Inc.

More Information

No publications provided

Responsible Party:	Eisai Medical Research Inc. ( Guillermo Rossiter, M.D. )
Study ID Numbers:	E3810-G000-306, EudraCT No. 2007-007733-39
Study First Received:	February 5, 2009
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00839306 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

Gastroesophageal
Reflux
Disease
GERD

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Histamine Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Histamine H2 Antagonists
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Ranitidine
Digestive System Diseases
Histamine Antagonists
Ranitidine bismuth citrate
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on February 08, 2010