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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.
• Treatments: Rebamipide

Criteria

Inclusion Criteria:

• Diagnosed with acute gastritis or chronic gastritis

• 1 or more erosions found in the gastroscope examination

• Age should be: 20≤age≤75

Exclusion Criteria:

• A patient with peptic ulcer and a gastroesophageal reflux disease.

• Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation

• Had a surgery regarding gastroesophageal

• A patient with Zollinger-Ellison syndrome

• Had a medical history of a malignant tumor

• A patient who is currently taking anti-thrombotic drugs