NCT00299013

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 796 (actual)
• Sponsor: Alizyme · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-03-06
• Last updated: 2008-04-25

Locations

86 sites across 15 countries: Australia, Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Russia, South Africa, Spain, Sweden, United Kingdom