A randomised trial of early endoscopy, Helicobacter pylori (Hp) testing or empiric treatment for dyspepsia

ISRCTN ISRCTN84808638
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

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
Email richard.logan@nottingham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study objectivesA 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) studiedPeptic ulcer disease
Intervention1. 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/05/1995
Completion date01/11/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients newly presenting with dyspectic symptoms
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/05/1995
Date of final enrolment01/11/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Faculty of Medicine
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2009 Yes No