Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Brendan Delaney
ORCID ID
Contact details
Department of Primary Care & General Practice
The Medical School
Edgbaston
Birmingham
B15 2TT
United Kingdom
b.c.delaney@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0001078
Study information
Scientific title
Acronym
CUBE
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/03/2002
Overall trial end date
28/02/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients age 18-65 years consulting GP with dyspepsia (either with a new episode or for follow up).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target number: 2000; Number actually enrolled: 699
Participant 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
Recruitment start date
01/03/2002
Recruitment end date
28/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/18310262
Publication citations
-
Results
Delaney BC, Qume M, Moayyedi P, Logan RF, Ford AC, Elliott C, McNulty C, Wilson S, Hobbs FD, Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial)., BMJ, 2008, 336, 7645, 651-654, doi: 10.1136/bmj.39479.640486.AE.