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

Perianal Crohn's Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01442363
• Other study ID #: PCD-02
• Status: Terminated
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2023
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Perianal Crohn's Disease

Intervention

Drug:
• BLI-1300 low dose
topical ointment
• BLI-1300 high dose
topical ointment
• placebo
topical ointment

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Perianal Pain Responders	Percent of responders during Week 12. Response is defined as =30% decrease in mean NRS score for perianal pain (for the 7 treatment days immediately preceding the Week 12 visit) compared to the screening period.	12 weeks