Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Asp-Fam-01/ Version 3
Study information
Scientific title
FAMOtidine for the prevention of peptic UlcerS in users of low-dose aspirin: a placebo-controlled prospective trial
Acronym
FAMOUS Trial
Study hypothesis
Given its efficacy against peptic ulcers induced by conventional non-steroidal anti-inflammatory drugs (NSAIDs), famotidine 40 mg daily might also be effective against upper gastrointestinal (GI) side effects of low-dose aspirin.
Please note that as of 11/02/2009 this record was updated to include amended trial dates. The initial trial dates at the time of registration were:
Initial anticipated start date: 01/01/2006
Initial anticipated end date: 01/07/2009
Ethics approval
Added 11/02/2009: NHS Ayrshire and Arran Research Ethics Committee gave approval on the 17th January 2005 (ref: 587-MAR04C)
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Oesophageal, gastric and duodenal ulcers
Intervention
Interventions: famotidine 40 mg versus placebo
Screening: clinical and endoscopic assessment to identify patients who satisfy the inclusion and exclusion criteria. Clinical assessment at 6 weeks. Clinical and endoscopic assessment at 12 weeks.
Intervention type
Drug
Phase
Phase III
Drug names
Aspirin, famotidine
Primary outcome measure
To study the effect of Famotidine 40 mg daily versus placebo for up to 3 months for the prevention of oesophageal, gastric, and duodenal ulcers in subjects taking low-dose aspirin for its anti-thrombotic effect.
Secondary outcome measures
1. To study the effect of Famotidine 40 mg daily versus placebo for up to 3 months for the prevention of oesophageal, gastric, and duodenal erosions and submucosal haemorrhages in subjects taking low-dose aspirin for its anti-thrombotic effect
2. To study the effect of Famotidine 40 mg daily versus placebo for up to 3 months for the treatment or prevention of symptoms of acid reflux or ulcer-like dyspepsia in subjects taking low-dose aspirin for its anti-thrombotic effect
Overall trial start date
26/04/2006
Overall trial end date
01/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
700 patients: 350 to take famotidine and 350 to take placebo
Participant 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)
Recruitment start date
26/04/2006
Recruitment end date
01/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Crosshouse Hospital
Kilmarnock
KA2 0BE
United Kingdom
Funders
Funder type
Industry
Funder name
Yamanouchi Corporation (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19577798
Publication citations
-
Results
Taha AS, McCloskey C, Prasad R, Bezlyak V, Famotidine for the prevention of peptic ulcers and oesophagitis in patients taking low-dose aspirin (FAMOUS): a phase III, randomised, double-blind, placebo-controlled trial., Lancet, 2009, 374, 9684, 119-125, doi: 10.1016/S0140-6736(09)61246-0.