drugset / Trial / NCT01813812

A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034

NCT01813812

Phase 3 Unknown 492 enrolled Dong-A Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.

Timeline

Start
2010-10
Primary completion
2013-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject RECOFLAVONE Small molecule 45 mg
Subject RECOFLAVONE Small molecule 90 mg
Comparator Rebamipide Small molecule 300 mg

Indications