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

Dong-A ST

Status and phase

Unknown

Phase 3

Conditions

Chronic Gastritis

Acute Gastritis

Treatments

Drug: Stillen tab.

Drug: DA-5204

Study type

Interventional

Funder types

Industry

Identifiers

NCT02282670

DA5204_GR_III

Details and patient eligibility

About

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.

Enrollment

434 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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