Helicobacter testing to rationalise use of endoscopy

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Prof Roger Jones

ORCID ID

Contact details

General Practice & Primary Care
Guy’s
King’s & St Thomas’ School of Medicine
5 Lambeth Walk
London
SE11 6SP
United Kingdom
+44 (0)207 735 8881/2
roger.jones@kcl.ac.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

PSI03-32

Scientific title

Acronym

Study hypothesis

To determine whether the use of a Helicobacter pylori 'test and treat' strategy in general practice was associated with any improvement in clinical outcome or resource utilisation.

Ethics approval(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

GP practice

Study type

Treatment

Patient information sheet

Condition

Peptic ulcer disease

Intervention

Randomised trial comparing a Helicobacter pylori test-and-treat strategy with referral to direct access endoscopy in the management of dyspepsia in general practice.

Intervention type

Drug

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

Helicobacter pylori

Primary outcome measure

1. Health care utilisation
2. Consulting rates
3. Prescribing rates

Secondary outcome measures

No secondary outcome measures

Overall study start date

01/05/1995

Overall study end date

01/09/1998

Reason abandoned (if study stopped)

Participant inclusion criteria

A control group of practices in south east London pursuing 'usual' management of Helicobacter pylori, including endoscopy compared with a study group in which a near-patient test kit for Helicobacter pylori was provided for use on all patients under the age of 45 with persistent dyspepsia.

Participant type(s)

Patient

Age group

Adult

Sex

Both

Target number of participants

232

Participant exclusion criteria

Does not meet with inclusion criteria

Recruitment start date

01/05/1995

Recruitment end date

01/09/1998

Countries of recruitment

England, United Kingdom

Study participating centre

General Practice & Primary Care
London
SE11 6SP
United Kingdom

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

http://www.doh.gov.uk

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

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs