Contact information
Type
Scientific
Primary contact
Prof Richard Logan
ORCID ID
Contact details
Faculty of Medicine
Department of Public Health Medicine and Epidemiology
University of Nottingham
University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)1602 709308
richard.logan@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSI03-01
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/05/1995
Overall trial end date
01/11/1998
Reason abandoned
Eligibility
Participant inclusion criteria
Patients newly presenting with dyspectic symptoms
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
01/05/1995
Recruitment end date
01/11/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Faculty of Medicine
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18801056
Publication citations
-
Results
Duggan AE, Elliott CA, Miller P, Hawkey CJ, Logan RF, Clinical trial: a randomized trial of early endoscopy, Helicobacter pylori testing and empirical therapy for the management of dyspepsia in primary care., Aliment. Pharmacol. Ther., 2009, 29, 1, 55-68, doi: 10.1111/j.1365-2036.2008.03852.x.