Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion
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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
| Condition | Intervention | Phase |
|---|---|---|
|
Peptic Ulcer/Erosions |
Drug: pantoprazole vs famotidine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study |
- The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 161 |
| Study Start Date: | August 2004 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: pantoprazole
pantoprazole 20 mg om and matching placebo nocte
|
Drug: pantoprazole vs famotidine
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
Other Names:
|
|
Active Comparator: famotidine
Famotidine 40 mg om and nocte
|
Drug: pantoprazole vs famotidine
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr Fook Hong Ng, Ruttonjee Hospital |
| ClinicalTrials.gov Identifier: | NCT00843063 History of Changes |
| Other Study ID Numbers: | HKEC 2004-016 |
| Study First Received: | February 12, 2009 |
| Last Updated: | February 12, 2009 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Ruttonjee Hospital:
|
pantoprazole famotidine aspirin |
dyspepsia gastrointestinal bleeding peptic ulcer / erosion |
Additional relevant MeSH terms:
|
Peptic Ulcer Ulcer Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Pathologic Processes Aspirin Pantoprazole Famotidine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |
ClinicalTrials.gov processed this record on May 22, 2013