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

• Status: Unknown status
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.

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