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The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI4900 | Experimental | Experimental bowel preparation solution for oral ingestion |
|
| FDA Approved Control | Active Comparator | FDA approved bowel preparation solution for oral ingestion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bowel Prep | Drug | Orally ingested liquid bowel preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Successful Bowel Preparation | Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor). | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan | Braintree Laboratories / Sebela Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 301 Research Site 18 | Huntsville | Alabama | 38501 | United States | ||
| 301 Research Site 24 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI4900 | Experimental bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation |
| FG001 | FDA Approved Control | FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2020 |
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| Sun City |
| Arizona |
| 85351 |
| United States |
| 301 Research Site 7 | San Diego | California | 92114 | United States |
| 301 Research Site 16 | Clearwater | Florida | 33756 | United States |
| 301 Research Site 12 | Jacksonville | Florida | 32216 | United States |
| 301 Research Site 9 | Palm Harbor | Florida | 34684 | United States |
| 301 Research Site 4 | Palmetto Bay | Florida | 33157 | United States |
| 301 Research Site 26 | Port Orange | Florida | 32127 | United States |
| 301 Research Site 14 | St. Petersburg | Florida | 33709 | United States |
| 301 Research Site 25 | Sunrise | Florida | 33351 | United States |
| 301 Research Site 2 | Decatur | Georgia | 30033 | United States |
| 301 Research Site 10 | Indianapolis | Indiana | 46202 | United States |
| 301 Research Site 3 | Monroe | Louisiana | 71201 | United States |
| 301 Research Site 17 | Shreveport | Louisiana | 71105 | United States |
| 301 Research Site 11 | Flowood | Mississippi | 39232 | United States |
| 301 Research Site 13 | Chesterfield | Missouri | 48047 | United States |
| 301 Research Site 19 | Reno | Nevada | 89511 | United States |
| 301 Research Site 15 | Brooklyn | New York | 11235 | United States |
| 301 Research Site 5 | Great Neck | New York | 11023 | United States |
| 301 Research Site 23 | New York | New York | 10033 | United States |
| 301 Research Site 6 | Raleigh | North Carolina | 27612 | United States |
| 301 Research Site 21 | Mentor | Ohio | 44060 | United States |
| 301 Research Site 20 | Hixson | Tennessee | 37434 | United States |
| 301 Research Site 1 | Ogden | Utah | 84405 | United States |
| 301 Research Site 22 | Milwaukee | Wisconsin | 53215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI4900 | Experimental bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation |
| BG001 | FDA Approved Control | FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Proportion of Subjects With Successful Bowel Preparation | Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor). | Modified intent-to-treat population - subjects who took any portion of the study preparation and did not discontinue due to a reason other than safety, efficacy or tolerability. | Posted | Count of Participants | Participants | 2 days |
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30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
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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 | BLI4900 | Experimental bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation | 0 | 233 | 1 | 233 | 46 | 233 |
| EG001 | FDA Approved Control | FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation | 0 | 243 | 0 | 243 | 34 | 243 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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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. | 7819646710 | studydirector@sebelapharma.com |
| Sep 29, 2023 |
| Prot_SAP_000.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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