Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
NCT ID: NCT00138840
Last Updated: 2008-12-04
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
PHASE2
282 participants
INTERVENTIONAL
2005-08-31
Brief Summary
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This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe, active Crohn's disease. Study visits include a screening visit, 9 treatment period visits over 6 months and a follow-up visit that will occur 30 days following the end of treatment. Study drug treatment will continue for up to 6 months.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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STA-5326 mesylate
Eligibility Criteria
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Inclusion Criteria
* Has Crohn's disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
* Has a Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive at Baseline.
Exclusion Criteria
* Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-Up period.
* Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-Up period.
* Has clinically significant hematologic, hepatic or renal laboratory abnormalities.
18 Years
75 Years
ALL
No
Sponsors
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Synta Pharmaceuticals Corp.
INDUSTRY
Principal Investigators
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Bruce Sands, MD
Role:
Massachusetts General Hospital
Locations
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Gastroenterology Associates
Little Rock, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Community Clinical Trials
Orange, California, United States
Medical Associates Research Group
San Diego, California, United States
Southern Clinical Research Consultants
Hollywood, Florida, United States
Borland Groover Clinic
Jacksonville, Florida, United States
Miami Research Associates
Miami, Florida, United States
Advanced Gastroenterology Highland Lakes Medical Center
Palm Harbor, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology
Atlanta, Georgia, United States
Univ. of Louisville Clinical Research Unit
Louisville, Kentucky, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Maryland Digestive Disease Research
Laurel, Maryland, United States
Capital Gastroenterology Consultants, P.A.
Silver Spring, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
Gastroenterology Research Associates
Cedar Knolls, New Jersey, United States
Asher Kornbluth, MD
New York, New York, United States
Rochester Institute for Digestive Diseases and Sciences, Inc.
Rochester, New York, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States
Wake Research Associates, LLC.
Raleigh, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Columbia Gastroenterology Associates, P.A.
Columbia, South Carolina, United States
Gastroenterology Center of the MidSouth
Germantown, Tennessee, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Austin Gastroenterology
Austin, Texas, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
University of Calgary Health Sciences
Calgary, Alberta, Canada
London Health Science Center South Street Campus
London, Ontario, Canada
London Health Science Center University Campus
London, Ontario, Canada
Saskatoon Medical Specialists
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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5326-07
Identifier Type: -
Identifier Source: org_study_id