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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

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.

Intervention(s) in this Clinical Trial

• Drug: COLAL-PRED®
  • COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
• Drug: Prednisolone
  • Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
• Experimental: 2
  • COLAL-PRED 40mg oral capsule, once daily for 8 weeks.
• Experimental: 3
  • COLAL-PRED 60mg oral capsule, once daily for 8 weeks.
• Experimental: 4
  • COLAL-PRED 80mg oral capsule, once daily for 8 weeks.

Primary Measures

• Disease activity index
  • Time Frame: After 4 and 8 weeks of treatment
    Safety Issue?: No
• Cortisol levels
  • Time Frame: After 4 and 8 weeks of treatment
    Safety Issue?: Yes

Secondary Measures

• Simple clinical colitis activity index
  • Time Frame: 8 weeks
    Safety Issue?: No
• Endoscopy
  • Time Frame: 8 weeks
    Safety Issue?: No
• Adverse events
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Laboratory tests
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alizyme

Overall Clinical Trial Officials and Contacts

Christopher Hawkey Principal Investigator University Hospital, Nottingham  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00299013

Study ID Number: ATL2502/020/CL

ClinicalTrials.gov Identifier: NCT00299013

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency