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

Sponsors and Collaborators:	National Taiwan University Hospital Department of Health, Taiwan
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00854880

Purpose

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.

Condition	Intervention	Phase
Erosive Gastritis	Drug: PDC339 Drug: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Gastritis

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

efficacy and safety of PDC-339

Secondary Outcome Measures:

improvement of clinical symptoms

Estimated Enrollment:	69
Study Start Date:	March 2005
Study Completion Date:	February 2006
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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;
Use of other investigational drugs within 30 days prior to the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854880

Locations

Taiwan
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

Department of Health, Taiwan

Investigators

Principal Investigator:

Jyh-Chin Yang, M.D.

Division of Gastroenterology, Department of Internal Medicine, National Taiwan University Hospital

More Information

No publications provided

Study ID Numbers:	921105, DOH94-TD-I-111-003
Study First Received:	September 12, 2005
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00854880 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Erosive Gastritis

Study placed in the following topic categories:

Acute Disease
Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases

Gastrointestinal Hemorrhage
Gastroenteritis
Hemorrhage
Gastritis

Additional relevant MeSH terms:

Acute Disease
Disease Attributes
Pathologic Processes
Stomach Diseases
Digestive System Diseases

Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Hemorrhage
Gastroenteritis
Gastritis

ClinicalTrials.gov processed this record on May 06, 2009