STA-5326 in Crohn's Disease Patients

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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