Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
This study has been completed.
Sponsor:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00838526
First received: February 5, 2009
Last updated: May 9, 2013
Last verified: March 2010
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease (GERD) |
Drug: Rabeprazole ER Drug: Ranitidine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
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 ]
| Enrollment: | 240 |
| Study Start Date: | August 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Rabeprazole ER
50 mg capsule, taken orally, once daily for 26 weeks.
Other Name: Aciphex
|
| Active Comparator: 2 |
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).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- 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: NCT00838526
Locations
| United States, Illinois | |
| Ltd. | |
| Moline, Illinois, United States, 61265 | |
| Midwest Clinical | |
| Moline, Illinois, United States, 61265 | |
| Research Associates | |
| Moline, Illinois, United States, 61265 | |
| Moline, Illinois, United States, 61265 | |
Sponsors and Collaborators
Eisai Inc.
Investigators
| Study Director: | Guillermo Rossiter, MD | Eisai Inc. |
More Information
No publications provided
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00838526 History of Changes |
| Other Study ID Numbers: | E3810-G000-305, EudraCT No. 2007-007732-26 |
| Study First Received: | February 5, 2009 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eisai Inc.:
|
Gastroesophageal Reflux Disease GERD |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Ranitidine Ranitidine bismuth citrate Rabeprazole Anti-Ulcer Agents |
Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013