---
title: "A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease"
nct_id: NCT01442363
overall_status: TERMINATED
phase: PHASE2
sponsor: Braintree Laboratories
study_type: INTERVENTIONAL
primary_condition: "Perianal Crohn's Disease"
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01442363.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01442363"
ct_last_update_post_date: 2023-11-13
last_seen_at: "2026-05-12T06:38:13.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease

**NCT ID:** [NCT01442363](https://clinicaltrials.gov/study/NCT01442363)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Lack of recruitment, discontinuation of program
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 4
- **Lead Sponsor:** Braintree Laboratories
- **Conditions:** Perianal Crohn's Disease
- **Start Date:** 2011-11
- **Completion Date:** 2012-10
- **CT.gov Last Update:** 2023-11-13

## Brief 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **BLI-1300 (low dose)** (EXPERIMENTAL) — Investigational Product (10%) Ointment
- **BLI-1300 (high dose)** (EXPERIMENTAL) — Investigational Product (20%) Ointment
- **placebo** (PLACEBO_COMPARATOR) — Placebo Ointment

## Interventions

- **BLI-1300 low dose** (DRUG) — topical ointment
- **BLI-1300 high dose** (DRUG) — topical ointment
- **placebo** (DRUG) — topical ointment

## Primary Outcomes

- **Percentage of Perianal Pain Responders** _(time frame: 12 weeks)_ — Percent of responders during Week 12. Response is defined as ≥30% decrease in mean NRS score for perianal pain (for the 7 treatment days immediately preceding the Week 12 visit) compared to the screening period.

## Locations (17)

- ACRI - Phase I, Anaheim, California, United States
- University of California - San Francisco, San Francisco, California, United States
- Borland Groover Clinic, Jacksonville, Florida, United States
- University of Maryland, Baltimore, Maryland, United States
- Chevy Chase Clinical Research, Chevy Chase, Maryland, United States
- Mayo Clinic, Rochester, Minnesota, United States
- South Jersey Gastroenterology, Marlton, New Jersey, United States
- Long Island Clinical Research Associates, Great Neck, New York, United States
- New York Center for Clinical Research, Lake Success, New York, United States
- Mount Sinai Medical Center, New York, New York, United States
- Asheville Gastroenterology, Asheville, North Carolina, United States
- UNC School of Medical, Chapel Hill, North Carolina, United States
- Consultants for Clinical Research, Cincinnati, Ohio, United States
- University Hospitals Case Medical Center, Cleveland, Ohio, United States
- Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
- Medical University of South Carolina, Charleston, South Carolina, United States
- Vanderbilt University Medical Center, Nashville, Tennessee, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.acri - phase i|anaheim|california|united states` — added _(2026-05-12)_
- `locations.university of california - san francisco|san francisco|california|united states` — added _(2026-05-12)_
- `locations.borland groover clinic|jacksonville|florida|united states` — added _(2026-05-12)_
- `locations.university of maryland|baltimore|maryland|united states` — added _(2026-05-12)_
- `locations.chevy chase clinical research|chevy chase|maryland|united states` — added _(2026-05-12)_
- `locations.mayo clinic|rochester|minnesota|united states` — added _(2026-05-12)_
- `locations.south jersey gastroenterology|marlton|new jersey|united states` — added _(2026-05-12)_
- `locations.long island clinical research associates|great neck|new york|united states` — added _(2026-05-12)_
- `locations.new york center for clinical research|lake success|new york|united states` — added _(2026-05-12)_
- `locations.mount sinai medical center|new york|new york|united states` — added _(2026-05-12)_
- `locations.asheville gastroenterology|asheville|north carolina|united states` — added _(2026-05-12)_
- `locations.unc school of medical|chapel hill|north carolina|united states` — added _(2026-05-12)_
- `locations.consultants for clinical research|cincinnati|ohio|united states` — added _(2026-05-12)_
- `locations.university hospitals case medical center|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.penn state hershey medical center|hershey|pennsylvania|united states` — added _(2026-05-12)_
- `locations.medical university of south carolina|charleston|south carolina|united states` — added _(2026-05-12)_
- `locations.vanderbilt university medical center|nashville|tennessee|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01442363.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01442363*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*