Condition category
Digestive System
Date applied
08/10/2005
Date assigned
26/10/2005
Last edited
13/07/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ali S. Taha

ORCID ID

Contact details

Crosshouse Hospital
Kilmarnock
KA2 0BE
United Kingdom

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 measures

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

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

Sponsor information

Organisation

Greater Glasgow NHS Board (UK)

Sponsor details

C/O Dr Judith Godden
West Research Office
Ground Floor Room 9
Western Infirmary
Glasgow
G11 6NT
United Kingdom

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19577798

Publication citations

  1. 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.

Additional files

Editorial Notes