A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas

NCT00321412 Phase 3 COMPLETED

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).

Details

Lead sponsor	Ocera Therapeutics
Phase	Phase 3
Status	COMPLETED
Enrolment	191
Start date	2006-03
Completion	2008-09

Conditions

• Inflammatory Bowel Disease
• Intestinal Fistula

Interventions

• AST-120

Primary outcomes

• Efficacy: The proportion of patients considered to be "treatment successes" defined by a reduction of at least 50% in the number of draining fistulas at both week 4 and week 8 of an 8 week treatment period — 8 weeks
• Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment — 8 weeks

Countries

United States, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Netherlands, Poland, United Kingdom