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PDC-339 in Acute Erosive Gastritis
NCT00854880Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2005
- Primary completion
- Dec 2005
- Countries
- 1
- Sponsor
- National Taiwan University Hospital
- Modality
- Small Molecules
- Drugs
- PDC339
- Conditions
- erosive gastritis
01
Overview
Phase 2, randomised, double-blind trial in erosive gastritis comparing PDC-339 with Placebo (2 arms). Primary endpoints: Change of endoscopic gastric integrity at 6 weeks and Efficacy and safety of PDC-339. Started Mar 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PDC-339
PDC-339 (American ginseng extract)
Placebo
Placebo comparator
03
Who it enrols
Adult patients (>20 years) with endoscopy-confirmed acute erosive gastritis (Lanza Score >= 2). Excludes patients with gastric malignancy, ulcers, varices, severe cardiac/renal/liver disease, or recent use of acid-suppressing medications.
04
Endpoints
Primary
Change of endoscopic gastric integrity
Efficacy and safety of PDC-339
Secondary
Change of the severity of symptom
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