STA-5326 in Crohn's Disease Patients

Completed · Phase 1/Phase 2

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00088062

Run by

Synta Pharmaceuticals Corp.

People needed

48

Starts

2004-02-01

Expected to finish

2004-11-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Clinical Therapeutics — Tucson, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Venture Research Institute, LLC — North Miami Beach, Florida, United States
• Shafran Gastoenterology Center — Winter Park, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Heart of America Research Institute — Topeka, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Long Island Clinical Research — Great Neck, New York, United States
• Rochester Institute for Digestive Diseases and Sciences, Inc — Rochester, New York, United States
• Carolina Research Associates — Charlotte, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• West Hills GI — Portland, Oregon, United States
• Blair Gastroenterology Associates — Altoona, Pennsylvania, United States
• Memphis Gastroenterology Group — Memphis, Tennessee, United States
• Nashville Medical Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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