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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT01442363
First received: September 26, 2011
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Perianal Crohn's Disease
 Drug: BLI-1300 low dose
Drug: BLI-1300 high dose
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Improvement in perianal pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in perianal pain from baseline to Week 12


Secondary Outcome Measures:
  • Improvement in perianal discharge [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in perianal discharge from baseline to Week 12


Enrollment: 8
Study Start Date: November 2011
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BLI-1300 (low dose)
Low dose BLI-1300
 Drug: BLI-1300 low dose
topical ointment
Experimental: BLI-1300 (high dose)
High dose BLI-1300
 Drug: BLI-1300 high dose
topical ointment
Placebo Comparator: placebo
placebo (vehicle)
 Drug: placebo
topical ointment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442363

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

No publications provided

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01442363     History of Changes
Other Study ID Numbers: PCD-02
Study First Received: September 26, 2011
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
Crohn's disease
perianal
inflammatory bowel disease
fistula

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013