Adjunctive heparin in moderate to severe ulcerative colitis: a randomised multicentre controlled trial

ISRCTN	ISRCTN33332764
DOI	https://doi.org/10.1186/ISRCTN33332764
Secondary identifying numbers	B1034 R&D BARTON

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 24/04/2009

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Roger Barton
Scientific

North Tyneside Hospital
Faculty of Medicine
Education Centre
Newcastle
NE29 8NH
United Kingdom

Phone	+44 (0)191 293 2576
Email	j.r.barton@ncl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Inflammatory bowel disease
Intervention	Heparin with corticosteroids versus corticosteroids alone. TRIAL HALTED DUE TO POOR RECRUITMENT.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Heparin, corticosteroids
Primary outcome measure	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 study start date	06/01/1998
Completion date	04/01/2001
Reason abandoned (if study stopped)	TRIAL HALTED DUE TO POOR RECRUITMENT.

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients presenting with moderate to severe ulcerative colitis
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	06/01/1998
Date of final enrolment	04/01/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

North Tyneside Hospital

Newcastle
NE29 8NH
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan