Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of DA-5204
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Acute Gastritis
Chronic Gastritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
434 Patients enrolled
Trial Details
Trial ID
NCT02282670
Start Date
April 1 2014
End Date
November 1 2014
Last Update
November 4 2014
Active Locations (1)
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1
Seoul National Universtiy, Bundang Hospital, IRB
Seongnam-si, Gyeonggi-do, South Korea, 463-707