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

Braintree Laboratories

Status and phase: Terminated; Phase 2

Conditions: Perianal Crohn's Disease

Treatments: Drug: BLI-1300 high dose; Drug: placebo; Drug: BLI-1300 low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01442363

PCD-02

Details and patient eligibility

About

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).

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 3 patient groups, including a placebo group

BLI-1300 (low dose)

Experimental group

Description:

Investigational Product (10%) Ointment

Treatment:

Drug: BLI-1300 low dose

BLI-1300 (high dose)

Experimental group

Description:

Investigational Product (20%) Ointment

Treatment:

Drug: BLI-1300 high dose

placebo

Placebo Comparator group

Description:

Placebo Ointment

Treatment:

Drug: placebo