Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Information source: Eisai Medical Research Inc.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)
Intervention: Rabeprazole ER (Drug); Ranitidine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Eisai Medical Research Inc. Official(s) and/or principal investigator(s):
Guillermo Rossiter, M.D., Study Director, Affiliation: Eisai Medical Research Inc.
Overall contact:
Eisai Medical Services, Phone: 1-888-422-4743
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).
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Secondary outcome measures will include: adverse events, electrocardiograms (ECGs), laboratory evaluations (hematology, blood chemistry, urinalysis, gastrin), gastric biopsies, physical exam and vital signs.
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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:
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), histamine
receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs
with 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 interfere
with the conduct of the study, the interpretation of study results, or the health of
the subject during the study.
6. Any condition that would make the subject, in the opinion of the investigator or
sponsor, unsuitable for the study.
Locations and Contacts
Eisai Medical Services, Phone: 1-888-422-4743
Midwest Clinical Research Associates, Ltd., Moline, Illinois 61265, United States; Recruiting
Additional Information
Starting date: August 2008
Last updated: February 6, 2009
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