Clinical trial NCT01442363: A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Perianal Crohn's Disease
Keywords: Crohn's disease
perianal
inflammatory bowel disease
fistula
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2011-09-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Disease (PCD).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Perianal Pain Responders
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: ACRI - Phase I
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Jacksonville
country: United States
facility: Borland Groover Clinic
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Marlton
country: United States
facility: South Jersey Gastroenterology
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Lake Success
country: United States
facility: New York Center for Clinical Research
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC School of Medical
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References: