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.

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.

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