Perianal Crohn's DiseasePhase 2NCT01442363
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
A Phase 2 study testing BLI-1300 low dose and BLI-1300 high dose in people with Perianal Crohn's Disease, run by Braintree Laboratories at 17 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Crohn's Disease
- What is being tested?
- BLI-1300 low dose and BLI-1300 high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2011to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
ACRI - Phase I
Anaheim, California, 92801
Asheville Gastroenterology
Asheville, North Carolina, 28801
University of Maryland
Baltimore, Maryland, 21201
UNC School of Medical
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Consultants for Clinical Research
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Long Island Clinical Research Associates
Great Neck, New York, 11021
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Borland Groover Clinic
Jacksonville, Florida, 32256
New York Center for Clinical Research
Lake Success, New York, 11042
South Jersey Gastroenterology
Marlton, New Jersey, 08053
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Mount Sinai Medical Center
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
University of California - San Francisco
San Francisco, California, 94115
About this study
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
- Being tested
- BLI-1300 low dose, BLI-1300 high dose, placebo
- Keywords
- Crohn's disease, perianal, inflammatory bowel disease, fistula
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI-1300 low doseDrug
topical ointment
BLI-1300 high doseDrug
topical ointment
placeboDrug
topical ointment
| Study group | Role | What they receive |
|---|---|---|
| BLI-1300 (low dose) | Experimental | Investigational Product (10%) Ointment Receives: Drug: BLI-1300 low dose |
| BLI-1300 (high dose) | Experimental | Investigational Product (20%) Ointment Receives: Drug: BLI-1300 high dose |
| placebo | Placebo comparator | Placebo Ointment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Perianal Pain Responders
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Lack of recruitment, discontinuation of program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perianal Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McGowan, MPH, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442363
- Sponsor's protocol ID
- PCD-02
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2011
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
- ClinicalTrials.gov ID
- NCT01442363
- Acronym / sponsor ID
- PCD-02
- Conditions
- Perianal Crohn's Disease
- Keywords
- Crohn's disease, perianal, inflammatory bowel disease, fistula
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment, discontinuation of program
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Nov 2011 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLI-1300 (low dose) | Experimental | Drug: BLI-1300 low doseInvestigational Product (10%) Ointment |
| BLI-1300 (high dose) | Experimental | Drug: BLI-1300 high doseInvestigational Product (20%) Ointment |
| placebo | Placebo comparator | Drug: placeboPlacebo Ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLI-1300 low dosetopical ointment | Drug | BLI-1300 (low dose) |
| BLI-1300 high dosetopical ointment | Drug | BLI-1300 (high dose) |
| placebotopical ointment | Drug | placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Perianal Crohn's Disease
Active, not recruitingPhase 3
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Fistulizing Crohns Disease, Perianal Crohns Disease
RecruitingPhase 4
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
Crohn Disease, Perianal Fistula
Recruiting
A Study Comparing Transperineal Ultrasound, Magnetic Resonance Imaging, Endoscopic Ultrasound, and Examination Under Anesthesia to Detect and Classify Perianal Fistulas in Patients With Crohn's Disease or Fistulas of Unknown Cause
Crohn Disease (CD), Cryptoglandular Perianal Fistula
Not yet recruitingPhase 1/2
Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study
Inflammatory Bowel Disease (IBD), Crohn Disease
Not yet recruitingPhase 4
MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
Crohn's Disease, Perianal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John McGowan, MPH study director
Braintree Laboratories, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BLI-1300 low dose and BLI-1300 high dose in people with Perianal Crohn's Disease, run by Braintree Laboratories at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Perianal Pain Responders (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.