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

March 20, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

492

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DA-6034 45mg
two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.
Drug: DA-6034
EXPERIMENTAL: DA-6034 90mg
two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.
Drug: DA-6034
ACTIVE_COMPARATOR: Rebamipide 300mg
two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.
Drug: Rebamipide 300mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of erosions diagnosed by the gastroscope
Time Frame: 2 weeks
2 weeks
The severity of the digestive symptoms (Scale of 1 to 5)
Time Frame: 2 weeks

the example of the symptoms are:

epigastralgia, heartburn, acid reflux, nausea, domperidone
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Hyun Chae Jung, M.D., Ph.D., Seoul National University Hospital
  • Principal Investigator: Soo Heon Park, M.D., Ph.D., Catholic University Yeouido St. Mary's Hopspital
  • Principal Investigator: Seong Woo Jeon, M.D., Ph.D., Kyungpook National University Hospital
  • Principal Investigator: Sang Woo Lee, M.D.,Ph.D., Korea University Ansan Hospital
  • Principal Investigator: Dong Ho Lee, M.D.,Ph.D., Seoul National University Bundang Hospital
  • Principal Investigator: Kook Lae Lee, M.D., Ph.D., SMG-SNU Boramae Medical Center
  • Principal Investigator: Ju Yung Cho, M.D., Ph.D., Soonchunhyang University Hospital
  • Principal Investigator: Ki Myeong Lee, M.D., Ph.D., Ajou University School of Medicine
  • Principal Investigator: Yongchan Lee, M.D., Ph.D., Severance Hospital, Yonsei University
  • Principal Investigator: Sang Yong Seol, M.D., Ph.D., Inje University
  • Principal Investigator: Jeong Seop Moon, M.D., Ph.D., Inje University
  • Principal Investigator: Jong Sun Rew, M.D., Ph.D., Chonnam National University Hospital
  • Principal Investigator: Soo Taek Lee, M.D., Ph.D., Chonbuk National University Hospital
  • Principal Investigator: Chan Kook Park, M.D., Ph.D., Chosun University Hospital
  • Principal Investigator: Jae Gyu Kim, M.D., Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine
  • Principal Investigator: Sei Jin Youn, M.D., Ph.D., Chungbuk National University Hospital
  • Principal Investigator: Hak Yang Kim, M.D., Ph.D., Hallym University Medical Center
  • Principal Investigator: Byung Chul Yoon, M.D., Ph.D., Hanyang University
  • Principal Investigator: Suck Chei Choi, M.D., Ph.D., Wonkwang University Hospital
  • Principal Investigator: Ki Nam Shim, M.D., Ph.D., Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (ESTIMATE)

March 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2013

Last Update Submitted That Met QC Criteria

March 20, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA6034_Gas_III (Version 4.3)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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