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 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 trial start date
06/01/1993
Overall trial end date
30/09/1997
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list