STA-5326 in Crohn's Disease Patients
- Conditions
- Crohn's Disease
- Registration Number
- NCT00088062
- Lead Sponsor
- Synta Pharmaceuticals Corp.
- Brief Summary
The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Patients 18-65 years old
- Crohn's Disease for 6 months
- CDAI scores between 220-450
- +/- 5-ASA, stable dose for > 2 weeks
- +/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks
- +/- Infliximab with no treatment within 4 weeks
- +/- 6-Mercaptopurine, with a stable dose for 8 weeks
- +/- Antibiotics, with a stable dose for 2 weeks
- Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening
- Pregnancy, breast feeding
- History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study
- Bowel obstruction
- Surgical bowel resection within 90 days
- Total parenteral nutrition (TPN), CYA, tacrolimus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Heart of America Research Institute
🇺🇸Topeka, Kansas, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Venture Research Institute, LLC
🇺🇸North Miami Beach, Florida, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Shafran Gastoenterology Center
🇺🇸Winter Park, Florida, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Carolina Research Associates
🇺🇸Charlotte, North Carolina, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Rochester Institute for Digestive Diseases and Sciences, Inc
🇺🇸Rochester, New York, United States
Long Island Clinical Research
🇺🇸Great Neck, New York, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Blair Gastroenterology Associates
🇺🇸Altoona, Pennsylvania, United States
West Hills GI
🇺🇸Portland, Oregon, United States
Memphis Gastroenterology Group
🇺🇸Memphis, Tennessee, United States