A randomised trial of early endoscopy, Helicobacter pylori (Hp) testing or empiric treatment for dyspepsia
ISRCTN | ISRCTN84808638 |
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DOI | https://doi.org/10.1186/ISRCTN84808638 |
Secondary identifying numbers | PSI03-01 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Richard Logan
Scientific
Scientific
Faculty of Medicine
Department of Public Health Medicine and Epidemiology
University of Nottingham
University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
Phone | +44 (0)1602 709308 |
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richard.logan@nottingham.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
Scientific title | |
Study objectives | A randomised trial of early endoscopy or testing for helicobacter pylori in patients newly consulting for dyspepsia. The trial will establish the benefits of early endoscopy versus two management strategies based on testing for helicobacter pylori in primary care compared to conventional empiric treatment with gastric acid reducing drugs. Benefits will be assessed in terms of symptom relief, patient satisfaction and disability, reconsultation rates, drug prescribing and diagnostic yield. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Peptic ulcer disease |
Intervention | 1. Early endoscopy 2. Management strategies based on testing for Helicobacter pylori in primary care 3. Conventional empiric treatment with gastric acid reducing drugs (control) |
Intervention type | Other |
Primary outcome measure | 1. Diagnosis 2. Drugs prescribed 3. Repeat consultations 4. Need for further investigation/referral 5. Symptom response 6. Self-medication 7. Time off work 8. Patient satisfaction and quality of life (36-item Short Form Health Survey [SF-36]) |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/05/1995 |
Completion date | 01/11/1998 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | Patients newly presenting with dyspectic symptoms |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/05/1995 |
Date of final enrolment | 01/11/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Faculty of Medicine
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/01/2009 | Yes | No |