Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.

Detailed Description
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Ulcerative colitis is a disease that causes inflammation of the large bowel, causing fever, diarrhoea, dehydration and other symptoms. Standard treatment for ulcerative colitis includes general medical treatments such as fluid and salt replacement and attention to diet. Anti-inflammatory medicines such as steroids (e.g. prednisolone) and aminosalicylates (e.g. mesalazine) are the main drug treatments. This study will investigate whether COLAL-PRED®, a novel dosage form of a prednisolone ester, is safe and effective in the treatment of ulcerative colitis, compared with the standard treatment (conventional prednisolone) and also to determine which dose which will work best for future patients.

Official Title
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A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: COLAL-PRED®
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endoscopically confirmed diagnosis of ulcerative colitis Score of 6-10 on the Disease Activity Index (DAI) Moderate to severe mucosal appearance Exclusion Criteria: Previous colonic surgery Other treatments for ulcerative colitis that have not been stabilised Clinically significant diabetes, heart failure, unstable angina, cirrhosis, renal failure History of tuberculosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks. | Drug: Prednisolone<br>* Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.<br>|
| Experimental: 2<br>COLAL-PRED 40mg oral capsule, once daily for 8 weeks. | Drug: COLAL-PRED®<br>* COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.<br>* Other names: Prednisolone sodium metasulfobenzoate.;|
| Experimental: 3<br>COLAL-PRED 60mg oral capsule, once daily for 8 weeks. | Drug: COLAL-PRED®<br>* COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.<br>* Other names: Prednisolone sodium metasulfobenzoate.;|
| Experimental: 4<br>COLAL-PRED 80mg oral capsule, once daily for 8 weeks. | Drug: COLAL-PRED®<br>* COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.<br>* Other names: Prednisolone sodium metasulfobenzoate.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity index |  | After 4 and 8 weeks of treatment | 
| Cortisol levels |  | After 4 and 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simple clinical colitis activity index |  | 8 weeks | 
| Endoscopy |  | 8 weeks | 
| Adverse events |  | 12 weeks | 
| Laboratory tests |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis