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NCT00088062 Clinical Trial

STA-5326 in Crohn's Disease Patients

Crohn's Disease Clinical Trial

Official title:
A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00088062
Other study ID # 5326-03
Secondary ID Crohn's DiseaseC
Status Completed
Phase Phase 1/Phase 2
First received July 19, 2004
Last updated June 23, 2005
Start date February 2004
Est. completion date November 2004

Study information
Verified date May 2005
Source Synta Pharmaceuticals Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date November 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• STA-5326

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

Sponsors (1)
Lead Sponsor Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

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