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 |
| Protocol serial number | 93020032 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- 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
Scientific
Endoscopy Centre
South Cleveland Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tripotassium dicitrato bismuthate, Metronidazole and oxytetracycline. |
| Primary outcome measure(s) |
Drug expenditure in the two practices will be compared and the number of patients restarting H2RA therapy. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Endoscopy Centre
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/10/2019: No publications found. All search options exhausted.
