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

NCT01442363 | Terminated Phase 2 Results

• 1 other identifier: PCD-02
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 17

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).

Conditions

Perianal Crohn's Disease

Keywords

Crohn's disease; perianal; inflammatory bowel disease; fistula

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

BLI-1300 (low dose)

EXPERIMENTAL

Investigational Product (10%) Ointment

Drug: BLI-1300 low dose

BLI-1300 (high dose)

EXPERIMENTAL

Investigational Product (20%) Ointment

Drug: BLI-1300 high dose

placebo

PLACEBO COMPARATOR

Placebo Ointment

Drug: placebo

Interventions

BLI-1300 low dose DRUG

topical ointment

BLI-1300 (low dose)

BLI-1300 high dose DRUG

topical ointment

BLI-1300 (high dose)

placebo DRUG

topical ointment

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (17)

ACRI - Phase I

Anaheim, California, 92801, United States

Location

University of California - San Francisco

San Francisco, California, 94115, United States

Location

Borland Groover Clinic

Jacksonville, Florida, 32256, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

South Jersey Gastroenterology

Marlton, New Jersey, 08053, United States

Location

Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

New York Center for Clinical Research

Lake Success, New York, 11042, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Asheville Gastroenterology

Asheville, North Carolina, 28801, United States

Location

UNC School of Medical

Chapel Hill, North Carolina, 27599, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Fistula

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head of R&D, GI
• Organization: Braintree Laboratories, Inc.

studydirector@sebelapharma.com

7818432202

Study Officials

• John McGowan, MPH

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Locations

US (17)