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
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