NCT01817556
Completed
Phase 4
A Multicenter, Active-controlled, Randomized, Double-blind Paralleled-group Clinical Trial to Evaluate the Efficacy of 4-week Treatment With Stillen Tab. in Patients With Acute or Chronic Gastritis
Overview
- Phase
- Phase 4
- Intervention
- Stillen Tab.
- Conditions
- Acute Gastritis
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 258
- Locations
- 1
- Primary Endpoint
- Improvement rates of erosive gastritis
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks.
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 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
- •Women either pregnant or breast feeding
Arms & Interventions
Stillen Tab.
administered three times daily for four weeks
Intervention: Stillen Tab.
Mucosta Tab.
administered three times daily for four weeks
Intervention: Mucosta Tab.
Outcomes
Primary Outcomes
Improvement rates of erosive gastritis
Time Frame: 4 weeks
Improvement rates of erosive gastritis (%) = (improved cases)/(total cases administered) \* 100
Secondary Outcomes
- Symptoms improved level(4 weeks)
- Healing rates of erosive gastritis(4 weeks)
Study Sites (1)
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