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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02282670
Recruitment Status : Unknown
Verified October 2014 by Dong-A ST Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2014
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Gastritis Chronic Gastritis Drug: DA-5204 Drug: Stillen tab. Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2014
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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]



Secondary Outcome Measures :
  1. 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. 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)].


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282670


Locations
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Korea, Republic of
Seoul National Universtiy, Bundang Hospital, IRB
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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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: Dae Hwan Kang, M.D., Ph.D. Pusan National University Yangsan Hospital of Korea
Principal Investigator: Yong Chan Lee, M.D., Ph.D. Yonsei University, Severance Hospital 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02282670    
Other Study ID Numbers: DA5204_GR_III
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases