drugset / Trial / NCT02135107

A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

NCT02135107 ↗

Phase 3 Completed 517 enrolled Eisai Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of rabeprazole 10mg once and twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.

Timeline

Start
2013-09
Primary completion
2016-05
Completion
2016-06

Outcome

Met primary endpoint

paper The no-recurrence rate at Week 52 was significantly higher in the b.i.d. group (73.9%; p < 0.001, χ2 test) than in the q.d. group (44.8%). PMID 29188387 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rabeprazole Small molecule 10 mg Oral
Subject Rabeprazole Small molecule 20 mg Oral