A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease



Status:Recruiting
Conditions:Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:November 2011
Contact:John McGowan, MPH
Email:jmcgowan@braintreelabs.com
Phone:781-843-2202

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This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is
designed to determine the effects of BLI-1300 ointment on perianal pain associated with
active Perianal Crohn's Disease (PCD).


Inclusion Criteria:

- All subjects must give written informed consent.

- Male or female subjects, 18 years of age.

- Confirmed diagnosis of Crohn's Disease.

- Subject must have a 3 month documented history of perianal Crohn's Disease (PCD) and
with clinical evidence of active PCD.

- Subject must have a Crohn's Disease Activity Index (CDAI) total score of ≤ 350 at
Visit 2.

- Subjects must have a qualifying perianal pain score at Visits 1 and 2.

Exclusion Criteria:

- Women of childbearing potential who are not using adequate contraception.

- Women who are pregnant or breastfeeding.

- Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF)
inhibitors, immunosuppressants, steroids).

- Subjects taking strong analgesics that could interfere with pain measurements.
Subjects with a perianal abscess requiring incision and drainage.

- Subjects with anal stenosis.

- Subjects with fistulae outside the immediate perianal area.

- Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks.

- Subjects who have had significant anorectal surgery for Crohns disease within the
past 8 weeks.
We found this trial at
17
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Great Neck, New York 11021
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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533 Parnassus Ave
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
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Anaheim, California 92801
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Asheville, North Carolina 28801
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Chevy Chase, Maryland 20815
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Cincinnati, Ohio 45211
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Lake Success, New York 11042
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Marlton, New Jersey 08053
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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