Clinical trial NCT00088062: STA-5326 in Crohn's Disease Patients
Official title: A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2004-07-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

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