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ISRCTN
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ISRCTN87644265
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DOI
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10.1186/ISRCTN87644265
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A multicentre randomised controlled trial of C13-Urea Breath testing and Helicobacter pylori eradication for dyspepsia in primary care
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Scientific title
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Acronym
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CUBE
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Serial number at source
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G0001078
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Study hypothesis
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1. To determine the cost-effectiveness of an H. pylori 'test and trust' strategy compared with initial acid suppression for the initial management of dyspensia in primary care
2. To determine the influence of selected patients on the basis of predominant heartburn or epigastic pain
3. To determine the performance of the H. pylori stool antigen (HpSA) test for H. pylori compared with a C13 Urea breath test for confirming H. pylori eradication in primary care
Please note that the target number of participants was added as of 06/03/2008.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Dyspepsia in primary care
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Participants - inclusion criteria
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All patients age 18-65 years consulting GP with dyspepsia (either with a new episode or for follow up).
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Participants - exclusion criteria
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1. Knowledge of previous test for H. pylori.
2. Patients who have a history suggestive of gastric cancer.i.e. dysphagia, weight loss, haematemesis or malaena, first-degree relative with gastric cancer.
3. Patient age 55-65 with continuous as opposed to episodic epigastric pain or a total history of any dyspeptic symptoms of less than a year at presentation (in accord with the National Health Service two week suspected cancer referral guidelines).
4. Knowledge of endoscopically proven peptic ulcer disease or severe oesophagitis (who should all receive either eradication therapy (ulcer) or proton pump inhibitor (oesophagitis)
5. Pregnant women
6. Patients who are unable to give informed consent
7. Patients taking regular non-steroidal anti-inflammatory drugs (who might have NSAID induced ulcers),or having started aspirin 75 - 150 mg in the past three months
8. Patients allergic to study drugs
9. Residents of USA or Canada
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Anticipated start date
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01/03/2002
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Anticipated end date
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28/02/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Target number: 2000; Number actually enrolled: 699
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Interventions
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All patients - will receive omeprazole 20mg once daily.
Study Group - C13 Urea breath test for H. pylori, using a test kit performed by the practice nurse. Patients testing positive will be offered H. pylori eradication with clarithromycin 250 mg twice daily and metronidazole 400 mg twice daily in addition to omeprazole. Patients testing negative will continue PPI (omeprazole).
Control Group - Patients will continue 4/52 PPI (omeprazole).
After four weeks patient management will be at the discretion of the general practitioner (GP). Patients receiving H. pylori eradication will be contacted by research staff and asked to attend for a follow-up breath test and produce a stool sample (for the stool antigen test) nine weeks after entry.
Follow-up will be by postal questionnaire at 12 weeks, interview at one year and a GP notes review (conducted by research staff).
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Primary outcome measure(s)
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1. Effects measured as absolute risk reduction for dyspeptic symptoms measured by the Short Form Leeds Dyspepsia score, a validated community-based measure that also includes a question on 'predominant symptoms'.
2. Health service related dyspepsia costs as determined by application of national reference costs to individual units of resource consumption (prescribing, consultations, interventions and investigations).
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Secondary outcome measure(s)
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1. Quality of life using Euro-QoL instrument (EQ-5D).
2. Patient satisfaction using the consultations Satisfaction Score (subscales one and two, general and professional care)
3. Performance of HpSA test
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Sources of funding
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Medical Research Council (UK)
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Trial website
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http://pcpoh.bham.ac.uk/primarycare/research/cube/
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18310262
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Contact name
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Dr
Brendan
Delaney
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Address
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Department of Primary Care & General Practice
The Medical School
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Email
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b.c.delaney@bham.ac.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Email
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Sponsor website:
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http://www.bham.ac.uk
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Date applied
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02/05/2001
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Last edited
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31/03/2009
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Date ISRCTN assigned
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02/05/2001
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