A Study to Evaluate the Efficacy and Safety of DA-5204
- Registration Number
- NCT02282670
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 434
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stillen tab. Stillen tab. Stillen tab. administered three times daily for two weeks DA-5204 DA-5204 DA-5204 administered two times daily for two weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 \[1-(total score of 7 days before termination of treatment)/(total score of 7 days before treatment)\].
Trial Locations
- Locations (1)
Seoul National Universtiy, Bundang Hospital, IRB
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of