Status:
TERMINATED
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
Lead Sponsor:
Braintree Laboratories
Conditions:
Perianal Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01442363
Start Date
November 1 2011
End Date
October 1 2012
Last Update
November 13 2023
Active Locations (17)
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1
ACRI - Phase I
Anaheim, California, United States, 92801
2
University of California - San Francisco
San Francisco, California, United States, 94115
3
Borland Groover Clinic
Jacksonville, Florida, United States, 32256
4
University of Maryland
Baltimore, Maryland, United States, 21201