Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion
Overview[ - collapse ][ - ]
| Purpose | 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 |
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| Condition | Peptic Ulcer/Erosions |
| Intervention | Drug: pantoprazole vs famotidine |
| Phase | Phase 4 |
| Sponsor | Ruttonjee Hospital |
| Responsible Party | Ruttonjee Hospital |
| ClinicalTrials.gov Identifier | NCT00843063 |
| First Received | February 12, 2009 |
| Last Updated | February 12, 2009 |
| Last verified | February 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 12, 2009 |
|---|---|
| Last Updated Date | February 12, 2009 |
| Start Date | August 2004 |
| Estimated Primary Completion Date | December 2008 |
| Current Primary Outcome Measures | The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions. [Time Frame: 48 weeks] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion |
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| Official Title | Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study |
| Brief 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
| Condition | Peptic Ulcer/Erosions |
| Intervention | Drug: pantoprazole vs famotidine pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte Other Names:
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| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 161 |
| Estimated Completion Date | December 2008 |
| Estimated Primary Completion Date | December 2008 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00843063 |
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| Other Study ID Numbers | HKEC 2004-016 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Ruttonjee Hospital |
| Study Sponsor | Ruttonjee Hospital |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Fook Hong Ng, M.D. Department of Medicine, Ruttonjee Hospital |
| Verification Date | February 2009 |
Locations[ + expand ][ + ]
| Ruttonjee Hospital | Wan Chai, Hong Kong, China |
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