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

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).

Study Overview

• Status: Terminated
• Conditions: Perianal Crohn's Disease
• Intervention / Treatment: Drug: BLI-1300 low dose; Drug: BLI-1300 high dose; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • ACRI - Phase I
    • San Francisco, California, United States, 94115
      • University of California - San Francisco
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Borland Groover Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Clinical Research
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • South Jersey Gastroenterology
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates
    • Lake Success, New York, United States, 11042
      • New York Center for Clinical Research
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology
    • Chapel Hill, North Carolina, United States, 27599
      • UNC School of Medical
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI-1300 (low dose); Investigational Product (10%) Ointment	Drug: BLI-1300 low dose; topical ointment
Experimental: BLI-1300 (high dose); Investigational Product (20%) Ointment	Drug: BLI-1300 high dose; topical ointment
Placebo Comparator: placebo; Placebo Ointment	Drug: placebo; topical ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in perianal discharge	Change in perianal discharge from baseline to Week 12	12 weeks

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: John McGowan, MPH, Braintree Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimated): September 28, 2011

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Crohn's disease; inflammatory bowel disease; fistula; perianal
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: PCD-02