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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Braintree Laboratories

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.