Status:
COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of PDC-339 for the Treatment of Acute Erosive Gastritis
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Conditions:
Erosive Gastritis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The primary biologically active components of ginseng are saponin triterpenoid glycosides called ginsenosides whose names relate to their chromatographic position (Ra, Rb, etc.). Based on the related ...
Eligibility Criteria
Inclusion
- 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
- 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;
- Use of other investigational drugs within 30 days prior to the study.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2006
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00854880
Start Date
March 1 2005
End Date
February 1 2006
Last Update
March 3 2009
Active Locations (1)
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1
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100