Study of COLAL-PRED® in the treatment of moderate acute ulcerative colitis

ISRCTN	ISRCTN71669877
DOI	https://doi.org/10.1186/ISRCTN71669877
ClinicalTrials.gov number	NCT00299013
Secondary identifying numbers	ATL2502/020/CL

Submission date: 10/03/2006
Registration date: 29/03/2006
Last edited: 31/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
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 Christopher J Hawkey
Scientific

University Hospital
Nottingham
NG7 2UH
United Kingdom

Study information

Study design	Randomised double-blind double-dummy active-comparator parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Study of COLAL-PRED® in the treatment of moderate acute ulcerative colitis
Study objectives	The aim of this study is 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.
Ethics approval(s)	Southampton and South West Hampshire Research Ethics Committees (A), 11/10/2005, ref: 05/Q1702/128
Health condition(s) or problem(s) studied	Moderate acute ulcerative colitis
Intervention	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
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	COLAL-PRED® containing prednisolone metasulfobenzoate sodium
Primary outcome measure	1. Responder analysis for reduction in disease activity index (DAI) score 2. Responder analysis for safety based on morning cortisol levels
Secondary outcome measures	Treatment responder analysis of patients who are both efficacy and safety responders
Overall study start date	07/03/2006
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	750
Key inclusion criteria	1. Endoscopically confirmed diagnosis of ulcerative colitis 2. Score of 6-10 on the disease activity index (DAI) 3. Moderate to severe mucosal appearance
Key exclusion criteria	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
Date of first enrolment	07/03/2006
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

Australia
Belgium
Czech Republic
Denmark
England
France
Germany
Hungary
Israel
Italy
Poland
Russian Federation
South Africa
Spain
Sweden
United Kingdom

Study participating centre

University Hospital

Nottingham
NG7 2UH
United Kingdom

Sponsor information

Alizyme (UK)
Industry

Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom

Phone	+44 (0)1223 896 000
Email	Medical.Information@alizyme.co.uk
Website	http://www.alizyme.com

Funders

Funder type

Industry

Alizyme (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 Company presentation of results in http://ww7.investorrelations.co.uk/alizyme/uploads/reports/0724COLAL-PREDresultsFINAL.pdf
IPD sharing plan

Editorial Notes

31/01/2019: No publications found. Added a company presentation of results to publication and dissemination plan
11/04/2017: No publications found in PubMed, verifying study status with principal investigator