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

ISRCTN	ISRCTN84808638
DOI	https://doi.org/10.1186/ISRCTN84808638
Protocol serial number	PSI03-01
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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])
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/11/1998

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

United Kingdom
England

Study participating centre

Faculty of Medicine

Nottingham
NG7 2UH
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

Study outputs

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