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

Primary Purpose

Perianal Crohn's Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BLI-1300 low dose
BLI-1300 high dose
placebo
Sponsored by
Braintree Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perianal Crohn's Disease focused on measuring Crohn's disease, perianal, inflammatory bowel disease, fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ACRI - Phase I
  • University of California - San Francisco
  • Borland Groover Clinic
  • University of Maryland
  • Chevy Chase Clinical Research
  • Mayo Clinic
  • South Jersey Gastroenterology
  • Long Island Clinical Research Associates
  • New York Center for Clinical Research
  • Mount Sinai Medical Center
  • Asheville Gastroenterology
  • UNC School of Medical
  • Consultants for Clinical Research
  • University Hospitals Case Medical Center
  • Penn State Hershey Medical Center
  • Medical University of South Carolina
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BLI-1300 (low dose)

BLI-1300 (high dose)

placebo

Arm Description

Low dose BLI-1300

High dose BLI-1300

placebo (vehicle)

Outcomes

Primary Outcome Measures

Improvement in perianal pain
Change in perianal pain from baseline to Week 12

Secondary Outcome Measures

Improvement in perianal discharge
Change in perianal discharge from baseline to Week 12

Full Information

First Posted
September 26, 2011
Last Updated
January 26, 2015
Sponsor
Braintree Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01442363
Brief Title
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Braintree Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Crohn's Disease
Keywords
Crohn's disease, perianal, inflammatory bowel disease, fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLI-1300 (low dose)
Arm Type
Experimental
Arm Description
Low dose BLI-1300
Arm Title
BLI-1300 (high dose)
Arm Type
Experimental
Arm Description
High dose BLI-1300
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo (vehicle)
Intervention Type
Drug
Intervention Name(s)
BLI-1300 low dose
Intervention Description
topical ointment
Intervention Type
Drug
Intervention Name(s)
BLI-1300 high dose
Intervention Description
topical ointment
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
topical ointment
Primary Outcome Measure Information:
Title
Improvement in perianal pain
Description
Change in perianal pain from baseline to Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improvement in perianal discharge
Description
Change in perianal discharge from baseline to Week 12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McGowan, MPH
Organizational Affiliation
Braintree Laboratories, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ACRI - Phase I
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Borland Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
South Jersey Gastroenterology
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
New York Center for Clinical Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Asheville Gastroenterology
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
UNC School of Medical
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

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

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