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

NCT00854880 | Completed Phase 2

• 2 other identifiers: 921105DOH94-TD-I-111-003
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Erosive Gastritis

Keywords

Erosive Gastritis

Outcome Measures

Primary Outcomes (1)

• efficacy and safety of PDC-339

Secondary Outcomes (1)

• improvement of clinical symptoms

Interventions

PDC339 DRUG

Placebo DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Department of Health, Executive Yuan, R.O.C. (Taiwan): collaborator

Study Sites (1)

Department of Internal Medicine, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

• Jyh-Chin Yang, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: March 3, 2009
• Study Start: March 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: February 1, 2006
• Last Updated: March 3, 2009

Record last verified: 2005-03

Locations

TW (1)