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

Phase 3

• Conditions: Acute Gastritis; Chronic Gastritis
• Interventions: Drug: Rebamipide 300mg; Drug: DA-6034

• Registration Number: NCT01813812
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Status Verified: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Last Update Submitted: 2013-03-20
• Last Update Posted: 2013-03-22
• Primary Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 492

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rebamipide 300mg	Rebamipide 300mg	two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.
DA-6034 45mg	DA-6034	two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.
DA-6034 90mg	DA-6034	two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.

Primary Outcome Measures

Name	Time	Method
The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).	2 weeks	The scale is classified into 5 steps which are based on the severity of the improvement.; EX) noticable improvement: 4-\>1, 3-\>1, slight improvement: 4-\>3, 3-\>2

Secondary Outcome Measures

Name	Time	Method
The number of erosions diagnosed by the gastroscope	2 weeks
The severity of the digestive symptoms (Scale of 1 to 5)	2 weeks	the example of the symptoms are: epigastralgia, heartburn, acid reflux, nausea, domperidone

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of