Peptic Ulcer/Erosions Clinical Trial
Official title:
Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study
| Verified date | February 2009 |
| Source | Ruttonjee Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Hong Kong: Ethics Committee |
| Study type | Interventional |
Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with
symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal
side effects.
The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer
or erosions by proton pump inhibitor is unclear.
The objective of this randomized, double blinded control study was to compare the efficacy
of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or
complicated ulcer/ erosions in patients taking low-dose aspirin
| Status | Completed |
| Enrollment | 161 |
| Est. completion date | December 2008 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg - endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum - they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks - 18 years old or older. Exclusion Criteria: - concurrent erosive or ulcerative esophagitis - pyloric stenosis - previous gastric or duodenal surgery other than oversewing of a perforation - thrombocytopenia - renal failure with estimated creatinine clearance less than 10 ml / min - active cancer - known allergic to aspirin, famotidine or pantoprazole - pregnancy, lactation, child-bearing potential in the absence of contraception - psychosomatic disorder - planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant - disorders that might modify the absorption of study drugs |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | Ruttonjee Hospital | Wan Chai | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Ruttonjee Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions. | 48 weeks | Yes |