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

Dong-A Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Chronic Gastritis; Acute Gastritis

Treatments: Drug: DA-6034; Drug: Rebamipide 300mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813812

DA6034_Gas_III (Version 4.3)

Details and patient eligibility

About

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.

Enrollment: 492 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

492 participants in 3 patient groups

DA-6034 45mg

Experimental group

Description:

two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.

Treatment:

Drug: DA-6034

DA-6034 90mg

Experimental group

Description:

two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.

Treatment:

Drug: DA-6034

Rebamipide 300mg

Active Comparator group

Description:

two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.

Treatment:

Drug: Rebamipide 300mg