Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI03-32

Study information

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

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

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

Phase

Not Applicable

Drug names

Helicobacter pylori

Primary outcome measures

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

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/1995

Overall trial end date

01/09/1998

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

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

Locations

Countries of recruitment

United Kingdom

Trial participating centre

General Practice & Primary Care
London
SE11 6SP
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

http://www.doh.gov.uk

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

1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10622066

Publication citations

  1. Results

    Jones R, Tait C, Sladen G, Weston-Baker J, A trial of a test-and-treat strategy for Helicobacter pylori positive dyspeptic patients in general practice., Int. J. Clin. Pract., 1999, 53, 6, 413-416.

Additional files

Editorial Notes