A Study to Evaluate the Efficacy and Safety of DA-5204
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
Lead SponsorDong-A Pharmaceutical
Indication/ConditionChronic Gastritis Acute 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.
DA-5204 administered two times daily for two weeks
Stillen tab. administered three times daily for two weeks
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