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Sponsored by: |
Ocera Therapeutics |
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Information provided by: | Ocera Therapeutics |
ClinicalTrials.gov Identifier: | NCT00321412 |
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).
Condition | Intervention | Phase |
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Inflammatory Bowel Disease Intestinal Fistula |
Drug: AST-120 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 240 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | September 2008 |
Arms | Assigned Interventions |
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2: Placebo Comparator
Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets
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Drug: AST-120
oral, sachet, 2 grams three times daily for 8 weeks
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1: Experimental
AST-120, 2 gram sachets
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Drug: AST-120
oral, sachet, 2 grams three times daily for 8 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Francois-Xavier Frapaise, MD | Ocera Therapeutics, Inc. |
Responsible Party: | Ocera Therapeutics, Inc. ( Laurent Fischer, MD ) |
Study ID Numbers: | AST001 |
Study First Received: | May 1, 2006 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00321412 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Netherlands: Dutch Health Care Inspectorate; Hungary: National Institute of Pharmacy; Austria: Agency for Health and Food Safety; Israel: Ministry of Health |
Crohn's disease IBD Inflammatory Bowel Disease Fistula |
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Fistula Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Fistula |
Digestive System Fistula |