- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00839306
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Illinois
-
Moline, Illinois, United States, 61265
-
Moline, Illinois, United States, 61265
- Associates, Ltd.
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Moline, Illinois, United States, 61265
- Midwest Clinical
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Moline, Illinois, United States, 61265
- Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
50 mg capsule, taken orally, once daily for 26 weeks.
Other Names:
|
Active Comparator: 2
|
150 mg capsule, taken orally, twice daily for 26 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
Time Frame: Baseline to Week 26
|
eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference. |
Baseline to Week 26
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
Time Frame: Baseline to Week 26
|
Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).
|
Baseline to Week 26
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Guillermo Rossiter, M.D., Eisai Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Histamine Antagonists
- Histamine Agents
- Histamine H2 Antagonists
- Rabeprazole
- Ranitidine
- Ranitidine bismuth citrate
Other Study ID Numbers
- E3810-G000-306
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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