Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

Eisai

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: Rabeprazole ER; Drug: Ranitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838526

E3810-G000-305

Details and patient eligibility

About

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).

Full 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).

Enrollment: 240 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Rabeprazole ER

2

Active Comparator group

Treatment:

Drug: Ranitidine