CompletedPhase 2

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

Taiwan69 participantsStarted 2005-03

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Patients \> 20 years old, male or female;
✓. Patients have endoscopy-based evidence (Lanza Score ≧ 2) of untreated acute erosive gastritis at examination;
✓. Having a negative result on a fecal occult blood test or hemoglobin below normal range of 2 g/dL;
✓. Patients who voluntarily signed written informed consent may participate in the study.

Exclusion criteria

✕. Pregnant or lactating female;\*
✕. Patients have endoscopy-based evidence of gastric malignancy, pyloric obstruction, and esophageal stricture requiring dilation, fresh clot, active bleeding, or perforated ulcers;
✕. Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations within 1 week before initiating study drug therapy;
✕. Patients requiring anticoagulants or corticosteroid therapy (at dosages greater than the equivalent of prednisone, 10 mg/day);
✕. 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;
✕. Any peptic ulcer at upper-gastrointestinal endoscopy;
✕. Patients with a history of esophageal and/or gastric varices;
✕. Known hypersensitivity to American ginseng;

What they're measuring

efficacy and safety of PDC-339

Trial details

NCT IDNCT00854880

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-12

View on ClinicalTrials.gov More Erosive Gastritis trials