Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2004-02-29
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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STA-5326
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Synta Pharmaceuticals Corp.
INDUSTRY
Locations
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Advanced Clinical Therapeutics
Tucson, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Venture Research Institute, LLC
North Miami Beach, Florida, United States
Shafran Gastoenterology Center
Winter Park, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Heart of America Research Institute
Topeka, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Long Island Clinical Research
Great Neck, New York, United States
Rochester Institute for Digestive Diseases and Sciences, Inc
Rochester, New York, United States
Carolina Research Associates
Charlotte, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
West Hills GI
Portland, Oregon, United States
Blair Gastroenterology Associates
Altoona, Pennsylvania, United States
Memphis Gastroenterology Group
Memphis, Tennessee, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Countries
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Other Identifiers
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Crohn's Disease
Identifier Type: -
Identifier Source: secondary_id
CDAI Scores of 220-450
Identifier Type: -
Identifier Source: secondary_id
5326-03
Identifier Type: -
Identifier Source: org_study_id