Clinical trial NCT00838526: Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal
Reflux
Disease
GERD
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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:

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.

Primary outcomes:
measure: Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
timeFrame: Baseline to Week 26
measure: Percentage of Participants With Adverse Events by Category
timeFrame: From the time of administration of the first dose of study drug up to a maximum of approximately 30 weeks.
Other outcomes:
Locations:
city: Moline
country: United States
facility: Ltd.
state: Illinois
city: Moline
country: United States
facility: Midwest Clinical
state: Illinois
city: Moline
country: United States
facility: Research Associates
state: Illinois
city: Moline
country: United States
state: Illinois
Study officials:
affiliation: Eisai Inc.
name: Guillermo Rossiter, MD
role: STUDY_DIRECTOR
References: