Status:
COMPLETED
STA-5326 in Crohn's Disease Patients
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00088062
Start Date
February 1 2004
End Date
November 1 2004
Last Update
June 24 2005
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
2
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
3
Venture Research Institute, LLC
North Miami Beach, Florida, United States, 33162
4
Shafran Gastoenterology Center
Winter Park, Florida, United States, 32789