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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01442363
Recruitment Status : Terminated
First Posted : September 28, 2011
Last Update Posted : January 27, 2015
Information provided by (Responsible Party):
Braintree Laboratories

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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2011
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement in perianal pain [ Time Frame: 12 weeks ]
    Change in perianal pain from baseline to Week 12

Secondary Outcome Measures :
  1. Improvement in perianal discharge [ Time Frame: 12 weeks ]
    Change in perianal discharge from baseline to Week 12

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01442363

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
Study Director: John McGowan, MPH Braintree Laboratories, Inc.

Responsible Party: Braintree Laboratories Identifier: NCT01442363     History of Changes
Other Study ID Numbers: PCD-02
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

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

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