Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
24/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Roger Barton

ORCID ID

Contact details

North Tyneside Hospital
Faculty of Medicine
Education Centre
Newcastle
NE29 8NH
United Kingdom
+44 (0)191 293 2576
j.r.barton@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B1034 R&D BARTON

Study information

Scientific title

Acronym

Study hypothesis

Ulcerative colitis (US) is characterised by a relapsing and remitting course. The mainstay of therapy for relapses is steroids, with non-responders needing immunosuppressants or surgery. Recently heparin has been used with encouraging results but has not been subjected to a randomised controlled trial. There are sound theoretical reasons why heparin might work, and if this is so, will not only lead to improved treatment for this lifelong disease, but also to further avenues of investigation of the aetiology of inflammatory bowel disease. The objectives are to test whether heparin given in combination with corticosteroids to patients presenting with moderate to severe ulcerative colitis will increase the proportion of patients responding to treatment when compared with patients receiving corticosteroids alone. This inaugural study for the Group would launch the study group, and would further stimulate enthusiasm for research, forming the basis for future collaborations between researchers in the Northern and Yorkshire regions and with the Northern and Yorkshire Clinical Trials and Research Unit.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Inflammatory bowel disease

Intervention

Heparin with corticosteroids versus corticosteroids alone.

TRIAL HALTED DUE TO POOR RECRUITMENT.

Intervention type

Drug

Phase

Not Applicable

Drug names

Heparin, corticosteroids

Primary outcome measures

The trial aims to assess the time to clinical response, the time to relapse, the health related quality of life of patients and the safety of the two treatment regimens.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/01/1998

Overall trial end date

04/01/2001

Reason abandoned

TRIAL HALTED DUE TO POOR RECRUITMENT.

Eligibility

Participant inclusion criteria

Patients presenting with moderate to severe ulcerative colitis

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

06/01/1998

Recruitment end date

04/01/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Tyneside Hospital
Newcastle
NE29 8NH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

Publication citations

Additional files

Editorial Notes