Status:
COMPLETED
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
Lead Sponsor:
Alizyme
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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
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 medica...
Eligibility Criteria
Inclusion
- Endoscopically confirmed diagnosis of ulcerative colitis
- Score of 6-10 on the Disease Activity Index (DAI)
- Moderate to severe mucosal appearance
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
796 Patients enrolled
Trial Details
Trial ID
NCT00299013
Start Date
March 1 2006
End Date
April 1 2008
Last Update
April 25 2008
Active Locations (86)
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1
Research Site
Bankstown, New South Wales, Australia, 2200
2
Research Site
Bedford Park, South Australia, Australia, 5042
3
Research Site
Parkville, Victoria, Australia, 3050
4
Research Site
Brussels, Belgium, 1070