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

NCT01442363 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-11-13

Study results available
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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).

Conditions

  • Perianal Crohn's Disease

Interventions

DRUG

BLI-1300 low dose

topical ointment

DRUG

BLI-1300 high dose

topical ointment

DRUG

placebo

topical ointment

Sponsors & Collaborators

  • Braintree Laboratories

    lead INDUSTRY

Principal Investigators

  • John McGowan, MPH · Braintree Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01442363 on ClinicalTrials.gov