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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Coliti

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 Summary:

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.


Sponsor: Alizyme

Current Primary Outcome:

  • Disease activity index [ Time Frame: After 4 and 8 weeks of treatment ]
  • Cortisol levels [ Time Frame: After 4 and 8 weeks of treatment ]


Original Primary Outcome:

  • Disease activity index
  • Cortisol levels


Current Secondary Outcome:

  • Simple clinical colitis activity index [ Time Frame: 8 weeks ]
  • Endoscopy [ Time Frame: 8 weeks ]
  • Adverse events [ Time Frame: 12 weeks ]
  • Laboratory tests [ Time Frame: 12 weeks ]


Original Secondary Outcome:

  • Simple clinical colitis activity index
  • Endoscopy
  • Adverse events
  • Laboratory tests


Information By: Alizyme

Dates:
Date Received: March 2, 2006
Date Started: March 2006
Date Completion:
Last Updated: April 24, 2008
Last Verified: April 2008