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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alizyme
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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