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Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion

Information source: Ruttonjee Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peptic Ulcer/Erosions

Intervention: pantoprazole vs famotidine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ruttonjee Hospital

Official(s) and/or principal investigator(s):
Fook Hong Ng, M.D., Principal Investigator, Affiliation: Department of Medicine, Ruttonjee Hospital

Summary

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

Clinical Details

Official title: Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.

Detailed description: Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease . Its use is frequently limited by gastrointestinal side effects, ranging from dyspepsia (31%) to life-threatening bleeding or perforation of gastroduodenal ulcers (3. 1%) over a period of 4 years . The best approach for the secondary prevention of low-dose aspirin induced symptomatic peptic ulcer or erosions in patients who need to continue aspirin remain uncertain. At present, eradication of Helicobacter pylori infection and long-term maintenance with proton pump inhibitor PPI appears to be the best options. The position of H2-receptor antagonists (H2RA) as a step-down therapy after healing of peptic ulcer or erosions 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ruttonjee Hospital, Wan Chai, Hong Kong, China
Additional Information

Starting date: August 2004
Last updated: February 12, 2009

Page last updated: August 23, 2015

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