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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 |
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| 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 |
|---|---|---|---|---|---|---|
| 302 Research Site 2 | Tucson | Arizona | 85712 | United States | ||
| 302 Research Site 10 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37490604 | Derived | Bhandari R, Goldstein M, Mishkin DS, McGowan J, Cleveland MV, Di Palma JA. Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy. J Clin Gastroenterol. 2023 Oct 1;57(9):920-927. doi: 10.1097/MCG.0000000000001894. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI4900 | Experimental bowel preparation solution for oral ingestion Bowel Prep (powder for oral solution): Orally ingested liquid bowel preparation (1 liter per dose) |
| FG001 | FDA Approved Control |
| 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 10, 2020 |
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| Little Rock |
| Arkansas |
| 72211 |
| United States |
| 302 Research Site 11 | North Little Rock | Arkansas | 72117 | United States |
| 302 Research Site 9 | Chula Vista | California | 91910 | United States |
| 302 Research Site 31 | Los Angeles | California | 90036 | United States |
| 302 Research Site 22 | Bristol | Connecticut | 06010 | United States |
| 302 Research Site 17 | Fleming Island | Florida | 32003 | United States |
| 302 Research Site 3 | Inverness | Florida | 34452 | United States |
| 302 Research Site 14 | Jacksonville | Florida | 32256 | United States |
| 302 Research Site 28 | Miami | Florida | 33134 | United States |
| 302 Research Site 29 | Miami | Florida | 33155 | United States |
| 302 Research Site 30 | Miami | Florida | 33155 | United States |
| 302 Research Site 38 | Palm Harbor | Florida | 34684 | United States |
| 302 Research Site 5 | Oak Lawn | Illinois | 60453 | United States |
| 302 Research Site 34 | Baton Rouge | Louisiana | 70809 | United States |
| 302 Research Site 26 | Mandeville | Louisiana | 70471 | United States |
| 302 Research Site 36 | Monroe | Louisiana | 71201 | United States |
| 302 Research Site 16 | Hagerstown | Maryland | 21742 | United States |
| 302 Research Site 39 | Brooklyn | New York | 11235 | United States |
| 302 Research Site 37 | Great Neck | New York | 11023 | United States |
| 302 Research Site 8 | Asheville | North Carolina | 28801 | United States |
| 302 Research Site 25 | High Point | North Carolina | 27262 | United States |
| 302 Research Site 1 | Raleigh | North Carolina | 27612 | United States |
| 302 Research Site 13 | Wilmington | North Carolina | 28403 | United States |
| 302 Research Site 18 | Cincinnati | Ohio | 45219 | United States |
| 302 Research Site 23 | Jackson | Tennessee | 38305 | United States |
| 302 Research Site 33 | Kingsport | Tennessee | 37660 | United States |
| 302 Research Site 32 | Cedar Park | Texas | 78613 | United States |
| 302 Research Site 21 | Houston | Texas | 77058 | United States |
| 302 Research Site 35 | Southlake | Texas | 76092 | United States |
| 302 Research Site 27 | Webster | Texas | 77598 | United States |
| 302 Research Site 6 | Charlottesville | Virginia | 22911 | United States |
| 302 Research Site 4 | Fairfax | Virginia | 22031 | United States |
| 302 Research Site 7 | Bellevue | Washington | 98004 | United States |
FDA approved bowel preparation solution for oral ingestion
Bowel Prep (liquid for reconstitution): Orally ingested liquid bowel preparation (16 oz per dose)
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| NOT COMPLETED |
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The Baseline Analysis Population represents the Intent-to-Treat Population which includes all patients that were dispensed a study preparation kit.
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 - this population includes all subjects that took any portion of study preparation and who did not withdraw for a reason other than safety, efficacy or tolerance. | 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 | 227 | 0 | 227 | 23 | 227 |
| EG001 | FDA Approved Control | FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation | 0 | 226 | 2 | 226 | 26 | 226 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| concussion | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| rectal hemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | 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. | 781-843-2202 | studydirector@sebelapharma.com |
| Sep 29, 2023 |
| Prot_SAP_000.pdf |
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| 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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