Suspended

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

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What is being tested

DA-6034

+ DA-6034

+ Rebamipide 300mg

Drug
Who is being recruted

From 20 to 75 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2010
See protocol details

Summary

Principal SponsorDong-A Pharmaceutical Co., Ltd.
Study ContactHyun Chae Jung, M.D., Ph.D.More contacts
Last updated: March 22, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01813812
Principal SponsorDong-A Pharmaceutical Co., Ltd.
Study ContactHyun Chae Jung, M.D., Ph.D.More contacts
Last updated: March 22, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

492 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
1 or more erosions found in the gastroscope examination
Age should be: 20 <= age <= 75
Diagnosed with acute gastritis or chronic gastritis
6 exclusion criteria prevent from participating
A patient who is currently taking anti-thrombotic drugs
A patient with Zollinger-Ellison syndrome
A patient with peptic ulcer and a gastroesophageal reflux disease
Had a medical history of a malignant tumor
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Seoul National University Hospital

Seoul, South KoreaOpen Seoul National University Hospital in Google Maps
SuspendedOne Study Center