drugset / Trial / NCT01813812
A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RECOFLAVONE | Small molecule | 45 mg | — |
| Subject | RECOFLAVONE | Small molecule | 90 mg | — |
| Comparator | Rebamipide | Small molecule | 300 mg | — |