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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Perianal Crohn's Disease

In brief

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).

Key facts

Study ID

NCT01442363

Run by

Braintree Laboratories

People needed

4

Starts

2011-11-01

Expected to finish

2012-10-01

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ACRI - Phase I — Anaheim, California, United States
• University of California - San Francisco — San Francisco, California, United States
• Borland Groover Clinic — Jacksonville, Florida, United States
• University of Maryland — Baltimore, Maryland, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• South Jersey Gastroenterology — Marlton, New Jersey, United States
• Long Island Clinical Research Associates — Great Neck, New York, United States
• New York Center for Clinical Research — Lake Success, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Asheville Gastroenterology — Asheville, North Carolina, United States
• UNC School of Medical — Chapel Hill, North Carolina, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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