A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD)

Phase 3 Completed 422 enrolled Janssen Pharmaceutica N.V., Belgium

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of long-term, "on-demand" maintenance therapy with rabeprazole in patients with non-erosive reflux disease (NERD).

Timeline

Start: 2001-10
Primary completion: —
Completion: 2002-10

Outcome

Met primary endpoint

paper 20% (28 of 139) for placebo vs. 6% (16 of 279) for rabeprazole (P < 0.00001). PMID 15233698 ↗

Publications

Results Bytzer P, Blum A, De Herdt D, Dubois D; Trial Investigators. Six-month trial of on-demand rabeprazole 10 mg maintains symptom relief in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2004 Jul 15;20(2):181-8. doi: 10.1111/j.1365-2036.2004.01999.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rabeprazole	Small molecule	10 mg	—