Erosive Gastritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Comparative Phase II Clinical Trial to Evaluate the Efficacy and Safety of PDC-339 for the Treatment of Acute Erosive Gastritis
Verified date | March 2005 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
The objective of this trial is to evaluate the efficacy and safety of PDC-339 in the treatment of acute erosive gastritis, using placebo as the comparator.
Status | Completed |
Enrollment | 69 |
Est. completion date | February 2006 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients > 20 years old, male or female; 2. Patients have endoscopy-based evidence (Lanza Score ? 2) of untreated acute erosive gastritis at examination; 3. Having a negative result on a fecal occult blood test or hemoglobin below normal range of 2 g/dL; 4. Patients who voluntarily signed written informed consent may participate in the study. Exclusion Criteria: 1. Pregnant or lactating female;* 2. Patients have endoscopy-based evidence of gastric malignancy, pyloric obstruction, and esophageal stricture requiring dilation, fresh clot, active bleeding, or perforated ulcers; 3. Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations within 1 week before initiating study drug therapy; 4. Patients requiring anticoagulants or corticosteroid therapy (at dosages greater than the equivalent of prednisone, 10 mg/day); 5. Patients with significant impairment of renal function (creatinine>2mg/dl); liver function impairment (AST and ALT 2x upper limit of normal); severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV) or acute respiratory disease; 6. Any peptic ulcer at upper-gastrointestinal endoscopy; 7. Patients with a history of esophageal and/or gastric varices; 8. Known hypersensitivity to American ginseng; 9. Use of other investigational drugs within 30 days prior to the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Internal Medicine, National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | Department of Health, Executive Yuan, R.O.C. (Taiwan) |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy and safety of PDC-339 | |||
Secondary | improvement of clinical symptoms |
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Completed |
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