A Clinical Trial to Evaluate the Efficacy and Safety of PDC-339 for the Treatment of Acute Erosive Gastritis

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: Department of Health, Executive Yuan, R.O.C. (Taiwan)

Criteria

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.