A multicentre randomised controlled trial of C13-Urea Breath testing and Helicobacter pylori eradication for dyspepsia in primary care
ISRCTN | ISRCTN87644265 |
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DOI | https://doi.org/10.1186/ISRCTN87644265 |
Secondary identifying numbers | G0001078 |
- Submission date
- 02/05/2001
- Registration date
- 02/05/2001
- Last edited
- 31/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Brendan Delaney
Scientific
Scientific
Department of Primary Care & General Practice
The Medical School
Edgbaston
Birmingham
B15 2TT
United Kingdom
b.c.delaney@bham.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Not Specified |
Scientific title | |
Study acronym | CUBE |
Study objectives | 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. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Dyspepsia in primary care |
Intervention | 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). |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | omeprazole, clarithromycin, metronidazole |
Primary outcome measure | 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). |
Secondary outcome measures | 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 |
Overall study start date | 01/03/2002 |
Completion date | 28/02/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | Target number: 2000; Number actually enrolled: 699 |
Key inclusion criteria | All patients age 18-65 years consulting GP with dyspepsia (either with a new episode or for follow up). |
Key exclusion criteria | 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 |
Date of first enrolment | 01/03/2002 |
Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
Website | http://www.bham.ac.uk |
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https://ror.org/03angcq70 |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 22/03/2008 | Yes | No |