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
Overview
- Phase
- Phase 3
- Intervention
- DA-5204
- Conditions
- Acute Gastritis
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 434
- Locations
- 1
- Primary Endpoint
- A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
- Last Updated
- 11 years ago
Overview
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 compared with Stillen® tab. in patients with acute or chronic gastritis.
Investigators
Eligibility 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.
Arms & Interventions
DA-5204
DA-5204 administered two times daily for two weeks
Intervention: DA-5204
Stillen tab.
Stillen tab. administered three times daily for two weeks
Intervention: Stillen tab.
Outcomes
Primary Outcomes
A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
Time Frame: 2 weeks
The definition of "moderate improvement" is the subjects showed score changed from 4 to 1 or from 2 to 1. And, "significant improvement" means the subject showed score changed from 4 to 1 or from 3 to 1. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]
Secondary Outcomes
- A percentage of completely cured subject after a treatment(2 weeks)
- A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.(2 weeks)