Prevention of oesophageal, gastric, and duodenal lesions in patients taking anti-thrombotic low-dose aspirin with famotidine

Completed

• Conditions: Oesophageal, gastric and duodenal ulcers; Digestive System; Gastric ulcer

• Registration Number: ISRCTN96975557
• Lead Sponsor: Greater Glasgow NHS Board (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Adult patients aged 18 years or over (either sex) and requiring low-dose aspirin, 75 - 325 mg daily
2. The presence of a stable and controlled indication for the anti-thrombotic effect of aspirin. This includes stable angina, previous myocardial infarction (12 or more weeks before recruitment), and peripheral vascular disease
3. The use of aspirin is likely to continue for 3 months or longer
4. The presence or absence of mild to moderate bearable dyspeptic or reflux symptoms
5. The presence or absence of gastric or duodenal erosions at base-line endoscopy

Exclusion Criteria

Any of the following is regarded as criterion for exclusion from the study:
1. History of oesophageal, gastric or duodenal surgery, excluding simple closure of an ulcer or vagotomy
2. Current or historical evidence of any of the following diseases:
2.1. Zollinger-Ellison syndrome
2.2. Primary oesophageal motility disorder(s) i.e. achalasia, scleroderma, primary oesophageal spasm
2.3. Evidence of upper GI malignancy at the pre-study endoscopy
2.4. Malabsorption
2.5. Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator to interfere with the evaluation of the study
2.6. Unstable diabetes mellitus (stable diabetes controlled by diet, oral agents or insulin is not an exclusion criterion)
2.7. Cerebrovascular disease such as cerebral ischaemia, infarction, haemorrhage or embolus as judged by the investigator to interfere with the evaluation of the study
2.8. Erosive oesophagitis at base-line endoscopy
2.9. Gastric ulcer and/or duodenal ulcer at base-line endoscopy or within the last 3 months
2.10. Inflammatory bowel disease
3. Suspected or confirmed current malignancy, except minor superficial skin disease
4. Complications related to gastroesophageal reflux disease (GORD) such as oesophageal stricture or confirmed low/high grade dysplasia of the oesophagus
5. Pregnancy or lactation. Women of childbearing potential will be required to maintain effective contraception during the study period as judged by the investigator.
6. Use of proton pump inhibitors, H2 receptor antagonists, or sucralfate within a week of the initial endoscopy
7. Treatment with a recognised H.pylori eradication regimen in the 28 days prior to Visit 1
8. Use of any other investigational compound or participation in another clinical trial within the 90 days prior to start of study medication
9. Need for continuous concomitant therapy with:
9.1. Anticholinergics (excluding eye drops and inhaled anticholinergics)
9.2. Cisapride
9.3. Prostaglandin analogues
9.4. Warfarin
9.5. High dose steroids (more than 7.5 mg of prednisolone or its equivalent daily)
9.6. Cytotoxic drugs
9.7. Non-steroidal anti-inflammatory drugs
9.8. Bisphosphonates used in the treatment or prevention of osteoporosis
10. Alcohol and/or drug abuse or any condition associated with poor compliance including expected non-cooperation, as judged by the investigator
11. Previous participation in this study
12. Contraindications to study drugs e.g. known or suspected allergy to famotidine
13. Need for interpreter (patients must be able to understand and complete the questionnaires in English)

Study & Design

• Study Type: Interventional
• Study Design: Not specified