Condition category
Digestive System
Date applied
10/03/2006
Date assigned
29/03/2006
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christopher J Hawkey

ORCID ID

Contact details

University Hospital
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00299013

Protocol/serial number

ATL2502/020/CL

Study information

Scientific title

Acronym

Study hypothesis

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

Southampton and South West Hampshire Research Ethics Committees (A), 11/10/2005, ref: 05/Q1702/128

Study design

Randomised double-blind double-dummy active-comparator parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

COLAL-PRED® containing prednisolone metasulfobenzoate sodium

Primary outcome measures

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 trial start date

07/03/2006

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

750

Participant 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

Recruitment start date

07/03/2006

Recruitment end date

31/03/2007

Locations

Countries of recruitment

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

Trial participating centre

University Hospital
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Alizyme (UK)

Sponsor details

Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
+44 (0)1223 896 000
Medical.Information@alizyme.co.uk

Sponsor type

Industry

Website

http://www.alizyme.com

Funders

Funder type

Industry

Funder name

Alizyme (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

Publication citations

Additional files

Editorial Notes