Trial | NCT02282670  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    434
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.
Study Started
Apr 30
2014
Primary Completion
Nov 30
2014
Anticipated
Study Completion
Nov 30
2014
Anticipated
Last Update
Nov 04
2014
Estimate

Drug DA-5204

Drug Stillen tab.

DA-5204 Experimental

DA-5204 administered two times daily for two weeks

Stillen tab. Active Comparator

Stillen tab. administered three times daily for two weeks

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
No Results Posted