A Study to Evaluate the Efficacy and Safety of DA-5204

October 31, 2014 updated by: Dong-A ST Co., Ltd.

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5204 and to Demonstrate the Non-inferiority of DA-5204 Compared With Stillen Tab. in Patients With Acute or Chronic Gastritis

This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

434

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
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National Universtiy, Bundang Hospital, IRB

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:

  • Age is over 20 years old, under 75 years old, men or women
  • Patients diagnosed with acute or chronic gastritis by gastroscopy
  • Patients with one or more erosions found by gastroscopy
  • Signed the informed consent forms

Exclusion Criteria:

  • Patients who is impossible to receive gastroscopy
  • Patients with peptic ulcer and gastroesophageal reflux disease
  • Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
  • Patients with surgery related to gastroesophageal
  • Patients with Zollinger-Ellison syndrome
  • Patients with any kind of malignant tumor
  • Patients administered with anti-thrombotic drugs
  • Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
  • Patients with neuropsychiatric disorder, alcoholism, or drug abuse
  • Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
  • Women either pregnant or breast feeding

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-5204
DA-5204 administered two times daily for two weeks
Drug: DA-5204
ACTIVE_COMPARATOR: Stillen tab.
Stillen tab. administered three times daily for two weeks
Drug: Stillen tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
Time Frame: 2 weeks

The definition of "moderate improvement" is the subjects showed score changed from 4 to 1 or from 2 to 1. And, "significant improvement" means the subject showed score changed from 4 to 1 or from 3 to 1.

[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A percentage of completely cured subject after a treatment
Time Frame: 2 weeks
The definition of "completely cured" is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy.
2 weeks
A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.
Time Frame: 2 weeks
The definition of "moderate improvement" is the subjects showed reduction ratio of score changed from 50% to 75%. And, "singnificant improvement" means the subjects showed reduction ratio of score changed 75% or more. Reduction ratio of score is calculated as [1-(total score of 7 days before termination of treatment)/(total score of 7 days before treatment)].
2 weeks

Collaborators and Investigators

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

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Dong Ho Lee, M.D., Ph.D., Seoul National University Bundang Hospital of Korea
  • Principal Investigator: Myung Gyu Choi, M.D., Ph.D., The Catholic University, Seoul St. Mary's Hospital of Korea
  • Principal Investigator: Sung Joon Lee, M.D., Ph.D., Kangwon National University Hospital of Korea
  • Principal Investigator: Sung Kuk Kim, M.D., Ph.D., Kyungbuk National University Hospital of Korea
  • Principal Investigator: Geun Am Song, M.D., Ph.D., Pusan National Universtiy Hospital of Korea
  • Principal Investigator: Poong Lyeol Lee, M.D., Ph.D., Samsung Medical Center of Korea
  • Principal Investigator: Hwoon Yong Jung, M.D., Ph.D., Asan Medical Center of Korea
  • Principal Investigator: Si Hyung Lee, M.D., Ph.D., Yeungnam University Hospital of Korea
  • Principal Investigator: Suck Chei Choi, M.D., Ph.D., Wonkwang University Hospital of Korea
  • Principal Investigator: Gi Nam Sim, M.D., Ph.D., Ewha Womans University Medical Center of Korea
  • Principal Investigator: Sang Young Seoul, M.D., Ph.D., Inje University Busan Paik Hospital of Korea
  • Principal Investigator: Jeong Seop Moon, M.D., Ph.D., Inje University Seoul Paik Hospital of Korea
  • Principal Investigator: Yong Woon Shin, M.D., Ph.D., Inha University Hospital of Korea
  • Principal Investigator: Hyen Soo Kim, M.D., Ph.D., Chonnam National Universtiy Hospital of Korea
  • Principal Investigator: Soo Teik Lee, M.D., Ph.D., Chonbuk National Universtiy Hospital of Korea
  • Principal Investigator: Jin Woong Cho, M.D., Ph.D., The Presbyterian medical center in Jeonju of Korea
  • Principal Investigator: Eun Kwang Choi, M.D., Ph.D., Jeju National Universtiy Hospital of Korea
  • Principal Investigator: Soon Man Yoon, M.D., Ph.D., Chungbuk National University Hospital of Korea
  • Principal Investigator: Oh Young Lee, M.D., Ph.D., Hanyang Universtiy Hospital of Korea
  • Principal Investigator: Jin Seok Jang, M.D., Ph.D., Dong-A university hospital of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2014

Primary Completion (ANTICIPATED)

November 1, 2014

Study Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (ESTIMATE)

November 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2014

Last Update Submitted That Met QC Criteria

October 31, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA5204_GR_III

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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