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

Sponsor

Ruttonjee Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00843063

Collaborator

(none)

161

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer/Erosions	Drug: pantoprazole vs famotidine	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

161 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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: pantoloc famotidine
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: pantoloc famotidine

Arm

Intervention/Treatment

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:

pantoloc

famotidine

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:

pantoloc

famotidine

Outcome Measures

Primary Outcome Measures

The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions. [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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