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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Christopher J Hawkey


Study Location:

University Hospital
Nottingham
NG7 2UH


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

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Moderate acute ulcerative colitis


Study summary

Not provided at time of registration

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.


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

Key dates

The recruitment start and end dates are as follows:

07 Mar 2006

31 Mar 2007

Study type

Interventional

Intervention Type : Drug
Intervention Name : COLAL-PRED® containing prednisolone metasulfobenzoate sodium
Intervention Description : Patients are randomised to receive one of the following interventions:1. Capsules containing prednisolone metasulfobenzoate sodium in a colonic delivery system2. Prednisolone tablets3. Matching placebo capsules and tablets


Who can take part?

You can take part if:


1. Endoscopically confirmed diagnosis of ulcerative colitis2. Score of 6-10 on the disease activity index (DAI)3. Moderate to severe mucosal appearance




You may not be able to take part if:

1. Previous colonic surgery2. Other treatments for ulcerative colitis that have not been stabilised3. Clinically significant diabetes4. Heart failure5. Unstable angina6. Cirrhosis7. Renal failure8. History of tuberculosis


Where can I take part?

Below are the locations for where you can take part in the trial.

  • University Hospital
    Nottingham
    NG7 2UH

Contact information

Prof Christopher J Hawkey


Funders/Sponsors


The study is sponsored by Alizyme (UK) and funded by Alizyme (UK) .



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for Trial ID: ISRCTN71669877

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