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ISRCTN
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ISRCTN71669877
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ClinicalTrials.gov identifier
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NCT00299013
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Public title
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Study of COLAL-PRED® in the treatment of moderate acute ulcerative colitis
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Scientific title
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Acronym
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N/A
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Serial number at source
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ATL2502/020/CL
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Study hypothesis
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To investigate whether COLAL-PRED® is non-inferior in terms of efficacy and superior in terms of safety to that of conventional prednisolone in the treatment of moderate acute ulcerative colitis
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Lay summary
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Ethics approval
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Approved by Southampton and South West Hampshire Research Ethics Committees (A) on 11 Oct 2005,
reference number: 05/Q1702/128
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Study design
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Randomised, double blind, double dummy, active comparator, parallel group
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Countries of recruitment
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Europe
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Disease/condition/study domain
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Moderate acute ulcerative colitis
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Participants - inclusion criteria
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1. Endoscopically confirmed diagnosis of ulcerative colitis
2. Score of 6-10 on the disease activity index (DAI)
3. Moderate to severe mucosal appearance
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Participants - exclusion criteria
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1. Previous colonic surgery
2. Other treatments for ulcerative colitis that have not been stabilised
3. Clinically significant diabetes
4. Heart failure
5. Unstable angina
6. Cirrhosis
7. Renal failure
8. History of tuberculosis
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Anticipated start date
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07/03/2006
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Anticipated end date
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31/03/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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750
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Interventions
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Patients are randomised to receive one of the following interventions:
1. Capsules containing prednisolone metasulfobenzoate sodium in a colonic delivery system
2. Prednisolone tablets
3. Matching placebo capsules and tablets
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Primary outcome measure(s)
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1. Responder analysis for reduction in disease activity index (DAI) score
2. Responder analysis for safety based on morning cortisol levels
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Secondary outcome measure(s)
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Treatment responder analysis of patients who are both efficacy and safety responders
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Sources of funding
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Alizyme (UK)
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Trial website
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Publications
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Contact name
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Prof
Christopher J
Hawkey
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Address
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University Hospital
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Sponsor
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Alizyme (UK)
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Address
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Granta Park
Great Abington
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City/town
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Cambridge
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Zip/Postcode
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CB1 6GX
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Country
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United Kingdom
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Tel
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+44 (0)1223 896 000
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Fax
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+44 (0)1223 896 001
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Email
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Medical.Information@alizyme.co.uk
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Sponsor website:
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http://www.alizyme.com
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Date applied
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10/03/2006
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Last edited
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29/03/2006
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Date ISRCTN assigned
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29/03/2006
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