Adjunctive heparin in moderate to severe ulcerative colitis: a randomised multicentre controlled trial
| ISRCTN | ISRCTN33332764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33332764 |
| Protocol serial number | B1034 R&D BARTON |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- 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
Scientific
North Tyneside Hospital
Faculty of Medicine
Education Centre
Newcastle
NE29 8NH
United Kingdom
| Phone | +44 (0)191 293 2576 |
|---|---|
| j.r.barton@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Heparin, corticosteroids |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 |
| 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
- United Kingdom
- England
Study participating centre
North Tyneside Hospital
Newcastle
NE29 8NH
United Kingdom
NE29 8NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
