Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Bramble

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

93020032

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Tripotassium dicitrato bismuthate, Metronidazole and oxytetracycline.

Primary outcome measures

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 trial start date

06/01/1993

Overall trial end date

30/09/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Patients on H2RAs

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

06/01/1993

Recruitment end date

30/09/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Endoscopy Centre
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes