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 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

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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18801056

Publication citations

  1. 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.

Additional files

Editorial Notes