NCT01813812

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

A Phase 3 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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 492 (estimated)
• Sponsor: Dong-A Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Gastritis
• Chronic Gastritis

Interventions

Type	Name	Description
DRUG	DA-6034
DRUG	Rebamipide 300mg

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-08-01
• First posted: 2013-03-19
• Last updated: 2013-03-22

Locations

1 site across 1 country: South Korea