Maintenance Intermittent Therapy for Symptomatic GERD Patients

Phase 2 Completed 200 enrolled Eisai Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal Reflux Disease (s-GERD).

Timeline

Start: 2004-10
Primary completion: 2005-12
Completion: 2008-06

Outcome

Met primary endpoint

paper The primary efficacy end point, mean percentage of heartburn-free days, was significantly greater with rabeprazole vs. placebo: 82.58% and 62.17% (ITT; P < 0.0001). PMID 20132154 ↗

Publications

Fass R, Delemos B, Nazareno L, Kao R, Xiang J, Lu Y. Clinical trial: maintenance intermittent therapy with rabeprazole 20 mg in patients with symptomatic gastro-oesophageal reflux disease - a double-blind, placebo-controlled, randomized study. Aliment Pharmacol Ther. 2010 May;31(9):950-60. doi: 10.1111/j.1365-2036.2010.04254.x. Epub 2010 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rabeprazole	Small molecule	20 mg	Oral