Condition category
Digestive System
Date applied
02/05/2001
Date assigned
02/05/2001
Last edited
31/03/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://pcpoh.bham.ac.uk/primarycare/research/cube/

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 measures

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

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

http://www.bham.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18310262

Publication citations

  1. 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.

Additional files

Editorial Notes