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

Completed · Phase 3

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

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).

Key facts

Study ID

NCT00838526

Run by

Eisai Inc.

People needed

240

Starts

2008-08-31

Expected to finish

2009-12-31

Last updated by the study team

2022-04-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ltd. — Moline, Illinois, United States
• Midwest Clinical — Moline, Illinois, United States
• Research Associates — Moline, Illinois, United States
• Study site — Moline, Illinois, United States

Full record on ClinicalTrials.gov

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