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Lack of recruitment, discontinuation of program
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI-1300 (low dose) | Experimental | Investigational Product (10%) Ointment |
|
| BLI-1300 (high dose) | Experimental | Investigational Product (20%) Ointment |
|
| placebo | Placebo Comparator | Placebo Ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI-1300 low dose | Drug | topical ointment |
| |
| BLI-1300 high dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan, MPH | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACRI - Phase I | Anaheim | California | 92801 | United States | ||
| University of California - San Francisco |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI-1300 (High Dose) | Investigational Product (20%) Ointment |
| FG001 | BLI-1300 (Low Dose) | Investigational Product (10%) Ointment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
topical ointment |
|
| placebo | Drug | topical ointment |
|
| San Francisco |
| California |
| 94115 |
| United States |
| Borland Groover Clinic | Jacksonville | Florida | 32256 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| South Jersey Gastroenterology | Marlton | New Jersey | 08053 | United States |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| New York Center for Clinical Research | Lake Success | New York | 11042 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Asheville Gastroenterology | Asheville | North Carolina | 28801 | United States |
| UNC School of Medical | Chapel Hill | North Carolina | 27599 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| FG002 | Placebo | Placebo Ointment |
| COMPLETED |
|
| NOT COMPLETED |
|
The study was discontinued and no patients were enrolled in the placebo arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI-1300 (High Dose) | Investigational Product (20%) Ointment |
| BG001 | BLI-1300 (Low Dose) | Investigational Product (10%) Ointment |
| BG002 | Placebo | Placebo Ointment |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The study was discontinued and no patients were enrolled in the placebo arm. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
12 weeks
The study was discontinued and no patients were enrolled in the placebo arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BLI-1300 (High Dose) | Investigational Product (20%) Ointment | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | BLI-1300 (Low Dose) | Investigational Product (10%) Ointment | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Placebo | Placebo Ointment | 0 | 0 | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rectal throbbing | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
The sole disclosure restriction which sponsor imposes on the PI is a sixty (60) day limited restriction in order to the protect potentially proprietary information which may be patentable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D, GI | Braintree Laboratories, Inc. | 7818432202 | studydirector@sebelapharma.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|