PCD-02

PCD-02

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).

2011-11-01

2012-10-01

2012-10-01

Terminated

Early phase I

4

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

2023-11-13