A community study to assess the cost benefits of eradicating Helicobacter pylori in patients on long term H2 Receptor Antagonists (H2RA)

ISRCTN ISRCTN54610315
DOI https://doi.org/10.1186/ISRCTN54610315
Secondary identifying numbers 93020032
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
24/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Michael Bramble
Scientific

Endoscopy Centre
South Cleveland Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA community study to assess the cost benefits of eradicating Helicobacter pylori in patients on long term H2 Receptor Antagonists (H2RA)
Study objectivesHospital based studies show that 'cure' of duodenal ulcer is possible if H.pylori is eradicated from the stomach. In Thornaby, there are two almost identical practices with large numbers of patients on H2RAs. The study aim is to recall all patients on long-term H2RAs, establish the diagnosis and treat H. pylori positive patients in one practice with Tripotassium dicitrato bismuthate, Metronidazole and Oxytetracycline. The incidence of H.pylori infection and success rate for eradicating the organism will be studied. One practice will act as a control. Patients will be interviewed by their own GP and treatment stopped. Investigation by gastroscopy, C13 urea breath test and serology will be at symptom relapse. An active 'placebo' regime will be given to patients from the control practice. All patients will be followed up for two years.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDigestive system diseases: Peptic ulcer disease
Intervention1. Treatment of H. Pylori positive patients with tripotassium dicitrato bismuthate, metronidazole and oxytetracycline.
2. Active 'placebo' regime
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Tripotassium dicitrato bismuthate, Metronidazole and oxytetracycline.
Primary outcome measureDrug expenditure in the two practices will be compared and the number of patients restarting H2RA therapy.
Secondary outcome measuresNot provided at time of registration
Overall study start date06/01/1993
Completion date30/09/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients on H2RAs
Key exclusion criteriaNot provided at time of registration
Date of first enrolment06/01/1993
Date of final enrolment30/09/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Endoscopy Centre
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

24/10/2019: No publications found. All search options exhausted.