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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01442363
• Date of registration: 26/09/2011
• Prospective Registration: Yes
• Primary sponsor: Braintree Laboratories
• Public title: A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
• Date of first enrolment: November 2011
• Target sample size: 8
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01442363
• 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
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: John McGowan, MPH
• Affiliation: Braintree Laboratories, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Perianal Crohn's Disease

Intervention(s)

Drug: BLI-1300 high dose

Drug: placebo

Drug: BLI-1300 low dose

Primary Outcome(s)

Improvement in perianal pain [Time Frame: 12 weeks]

Secondary Outcome(s)

Improvement in perianal discharge [Time Frame: 12 weeks]

Secondary ID(s)

PCD-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors