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NCT01442363 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
A Phase 2 study, sponsored by Braintree Laboratories.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01442363: Clinical Trial Phase 2 study, sponsored by Braintree Laboratories.
NCT01442363 is a Phase 2 study that was terminated before completion, run by Braintree Laboratories. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01442363, a Phase 2 study, was terminated before completion, sponsored by Braintree Laboratories.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG placebo
- DRUG BLI-1300 low dose
- DRUG BLI-1300 high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
Why NCT01442363 stopped before completion
NCT01442363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01442363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01442363 about?
NCT01442363 is a clinical study titled "A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease". 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).
What is the current status of trial NCT01442363?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2011-11. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01442363?
The interventions under investigation include: placebo (DRUG), BLI-1300 low dose (DRUG), BLI-1300 high dose (DRUG).
Who is sponsoring clinical trial NCT01442363?
This trial is sponsored by Braintree Laboratories, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01442363's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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