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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Gas

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 Summary: 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 studies, American ginseng was inferred to have the effects of modulating gastrointestinal system, lowering blood sugar level, enhancing memory, and suppressing mutation of breast cancer cell line. It also has anti-oxidant and neuroprotective effect. Among the experiences about the therapeutic uses of American ginseng, it is concluded that American ginseng is effective in treating gastrointestinal diseases. PDC339 is an active ingredient of American ginseng. This is a randomized, double blind, placebo-controlled parallel comparative phase II clinical trial to evaluate the efficacy and safety of PDC-339 in patients with acute erosive gastritis. The study period for each patient includes a screening/wash-out period of 1 week and a treatment period (including a 2-week follow-up) of 6 weeks. Subjects will be required to make a total of 5 visits. There will be a total of evaluable 60 patients (20 patients in each treatment group). If the drop out rate is assumed to be up to 10%, then there will be a total of 69 eligible patients. All of the subjects who meet the inclusion and exclusion criteria will be enrolled into the study and receive randomly either PDC-339 or placebo according a randomization list. The following clinical assessments will be performed: Primary efficacy assessment - the change of endoscopic gastric integrity; secondary efficacy assessment - the change of the severity of symptom on a 4-point scale at visit 3,4 from the baseline.
Sponsor: National Taiwan University Hospital

Current Primary Outcome: efficacy and safety of PDC-339

Original Primary Outcome: Same as current

Current Secondary Outcome: improvement of clinical symptoms

Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: September 12, 2005
Date Started: March 2005
Date Completion:
Last Updated: March 2, 2009
Last Verified: March 2005