Overview

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