STA-5326 in Crohn's Disease Patients
A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450
3 other identifiers
interventional
48
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2004
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 19, 2004
CompletedFirst Posted
Study publicly available on registry
July 21, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedJune 24, 2005
May 1, 2005
July 19, 2004
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Venture Research Institute, LLC
North Miami Beach, Florida, 33162, United States
Shafran Gastoenterology Center
Winter Park, Florida, 32789, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Heart of America Research Institute
Topeka, Kansas, 66614, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Long Island Clinical Research
Great Neck, New York, 10021, United States
Rochester Institute for Digestive Diseases and Sciences, Inc
Rochester, New York, 14607, United States
Carolina Research Associates
Charlotte, North Carolina, 28262, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
West Hills GI
Portland, Oregon, United States
Blair Gastroenterology Associates
Altoona, Pennsylvania, 16602, United States
Memphis Gastroenterology Group
Memphis, Tennessee, 38120, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 19, 2004
First Posted
July 21, 2004
Study Start
February 1, 2004
Study Completion
November 1, 2004
Last Updated
June 24, 2005
Record last verified: 2005-05