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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	A community study to assess the cost benefits of eradicating Helicobacter pylori in patients on long term H2 Receptor Antagonists (H2RA)
Study objectives	Hospital 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) studied	Digestive system diseases: Peptic ulcer disease
Intervention	1. Treatment of H. Pylori positive patients with tripotassium dicitrato bismuthate, metronidazole and oxytetracycline. 2. Active 'placebo' regime
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tripotassium dicitrato bismuthate, Metronidazole and oxytetracycline.
Primary outcome measure	Drug expenditure in the two practices will be compared and the number of patients restarting H2RA therapy.
Secondary outcome measures	Not provided at time of registration
Overall study start date	06/01/1993
Completion date	30/09/1997

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients on H2RAs
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	06/01/1993
Date of final enrolment	30/09/1997

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 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

Editorial Notes

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