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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00854880
Other study ID # 921105
Secondary ID DOH94-TD-I-111-0
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated March 2, 2009
Start date March 2005
Est. completion date February 2006

Study information

Verified date March 2005
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date February 2006
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. Patients > 20 years old, male or female;

2. Patients have endoscopy-based evidence (Lanza Score ? 2) of untreated acute erosive gastritis at examination;

3. Having a negative result on a fecal occult blood test or hemoglobin below normal range of 2 g/dL;

4. Patients who voluntarily signed written informed consent may participate in the study.

Exclusion Criteria:

1. Pregnant or lactating female;*

2. Patients have endoscopy-based evidence of gastric malignancy, pyloric obstruction, and esophageal stricture requiring dilation, fresh clot, active bleeding, or perforated ulcers;

3. Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations within 1 week before initiating study drug therapy;

4. Patients requiring anticoagulants or corticosteroid therapy (at dosages greater than the equivalent of prednisone, 10 mg/day);

5. 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;

6. Any peptic ulcer at upper-gastrointestinal endoscopy;

7. Patients with a history of esophageal and/or gastric varices;

8. Known hypersensitivity to American ginseng;

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
PDC339

Placebo


Locations

Country Name City State
Taiwan Department of Internal Medicine, National Taiwan University Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary efficacy and safety of PDC-339
Secondary improvement of clinical symptoms
See also
  Status Clinical Trial Phase
Completed NCT01578811 - Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis Phase 2
Completed NCT01689701 - Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis N/A