A Study to Evaluate the Efficacy and Safety of DA-5204
Study Details
Study Description
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 |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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
Primary Outcome Measures
- A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy. [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
- A percentage of completely cured subject after a treatment [2 weeks]
The definition of "completely cured" is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy.
- A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale. [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
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:
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Patients who is impossible to receive gastroscopy
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Patients with peptic ulcer and gastroesophageal reflux disease
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Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
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Patients with surgery related to gastroesophageal
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Patients with Zollinger-Ellison syndrome
-
Patients with any kind of malignant tumor
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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
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Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
-
Women either pregnant or breast feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National Universtiy, Bundang Hospital, IRB | Seongnam | Gyeonggi-do | Korea, Republic of | 463-707 |
Sponsors and Collaborators
- 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: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DA5204_GR_III