drugset / Trial / NCT01912066

A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601

NCT01912066

Phase 4 Completed 520 enrolled Dong-A ST Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.

Timeline

Start
2012-09
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Misoprostol Other / unclassified 200 ug
Subject Stillen Unknown
Background Aceclofenac Small molecule 100 mg

Indications