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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00843063
Other study ID # HKEC 2004-016
Secondary ID
Status Completed
Phase Phase 4
First received February 12, 2009
Last updated February 12, 2009
Start date August 2004
Est. completion date December 2008

Study information

Verified date February 2009
Source Ruttonjee Hospital
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
pantoprazole vs famotidine
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte

Locations

Country Name City State
China Ruttonjee Hospital Wan Chai Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Ruttonjee Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions. 48 weeks Yes