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The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI800 high dose | Experimental | BLI800 bowel preparation (high dose) |
|
| BLI800 low dose | Experimental | BLI800 bowel preparation (low dose) |
|
| PEG-ELS | Active Comparator | PEG based bowel preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-ELS | Drug | polyethylene glycol based bowel preparation |
| |
| BLI800 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects With Successful Bowel Cleansing | Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent) | 2 days |
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Inclusion Criteria:
Male or female between the ages of 12 to 16 (inclusive)
Undergoing colonoscopy for routinely accepted indications, including (but not limited to):
If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
Negative pregnancy test at screening, if applicable
In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Braintree Research Site 27 | Mobile | Alabama | 36582 | United States | ||
| Braintree Research Site 30 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI800 High Dose | BLI800 bowel preparation (high dose) BLI800: BLI800 bowel preparation (6 oz) |
| FG001 | BLI800 Low Dose | BLI800 bowel preparation (low dose) BLI800: BLI800 bowel preparation (4.5 oz) |
| 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 | Apr 18, 2016 |
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| Drug |
BLI800 bowel preparation |
|
| Tucson |
| Arizona |
| 85724 |
| United States |
| Braintree Research Site 23 | Orange | California | 92868 | United States |
| Braintree Research Site 16 | San Francisco | California | 94158 | United States |
| Braintree Research Site 5 | Gainesville | Florida | 32610 | United States |
| Braintree Research Site 24 | Jacksonville | Florida | 32207 | United States |
| Braintree Research Site 21 | Orlando | Florida | 32806 | United States |
| Braintree Research Site 2 | Atlanta | Georgia | 30342 | United States |
| Braintree Research Site 13 | Chicago | Illinois | 60611 | United States |
| Braintree Research Site 3 | Park Ridge | Illinois | 60068 | United States |
| Braintree Research Site 26 | Indianapolis | Indiana | 46202 | United States |
| Braintree Research Site 25 | Minneapolis | Minnesota | 55454 | United States |
| Braintree Research Site 18 | Rochester | Minnesota | 55905 | United States |
| Braintree Research Site 1 | Flowood | Mississippi | 39232 | United States |
| Braintree Research Site 9 | Buffalo | New York | 14222 | United States |
| Braintree Research Site 28 | New York | New York | 10021 | United States |
| Braintree Research Site 19 | New York | New York | 10032 | United States |
| Braintree Research Site 32 | The Bronx | New York | 10467 | United States |
| Braintree Research Site 6 | Pittsburgh | Pennsylvania | 15224 | United States |
| Braintree Research Site 20 | Memphis | Tennessee | 38103 | United States |
| Braintree Research Site 34 | Plano | Texas | 75093 | United States |
| Braintree Research Site 22 | Salt Lake City | Utah | 84118 | United States |
| Braintree Research Site 10 | Burlington | Vermont | 05401 | United States |
| Braintree Research Site 17 | Norfolk | Virginia | 23507 | United States |
| Braintree Research Site 4 | Roanoke | Virginia | 24013 | United States |
| Braintree Research Site 11 | Seattle | Washington | 98105 | United States |
| Braintree Research Site 14 | Milwaukee | Wisconsin | 53226 | United States |
| FG002 | PEG-ELS | PEG based bowel preparation PEG-ELS: polyethylene glycol based bowel preparation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Safety population - all subjects that took preparation.
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI800 High Dose | BLI800 bowel preparation (high dose) BLI800: BLI800 bowel preparation (6 oz) |
| BG001 | BLI800 Low Dose | BLI800 bowel preparation (low dose) BLI800: BLI800 bowel preparation (4.5 oz) |
| BG002 | PEG-ELS | PEG based bowel preparation PEG-ELS: polyethylene glycol based bowel preparation |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Number and Percentage of Subjects With Successful Bowel Cleansing | Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent) | Efficacy population | Posted | Count of Participants | Participants | 2 days |
|
|
|
|
30 days
Patients were directly queried for the expected bowel preparation symptoms of abdominal distension, abdominal pain, nausea and vomiting.
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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 | BLI800 High Dose | BLI800 bowel preparation (high dose) BLI800: BLI800 bowel preparation (6 oz) | 0 | 31 | 0 | 31 | 29 | 31 |
| EG001 | BLI800 Low Dose | BLI800 bowel preparation (low dose) BLI800: BLI800 bowel preparation (4.5 oz) | 0 | 28 | 0 | 28 | 26 | 28 |
| EG002 | PEG-ELS | PEG based bowel preparation PEG-ELS: polyethylene glycol based bowel preparation | 0 | 32 | 1 | 32 | 29 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alcohol intoxication | Injury, poisoning and procedural complications | MEDDRA | Non-systematic Assessment |
| |
| Accidental Tylenol Ingestion | Injury, poisoning and procedural complications | MEDDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Anion gap increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Anion gap decreased | Investigations | MedDRA (18.1) | 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, Gastroenterology | Braintree Laboratories, Inc. | 781-843-2202 | studydirector@sebelapharma.com |
| Apr 29, 2021 |
| Prot_SAP_000.pdf |
| 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 |
|
| Non-Inferiority |
Non-inferiority margin = 10% |
| Cochran-Mantel-Haenszel | 0.046 | Superiority |
| Cochran-Mantel-Haenszel | 0.089 | Superiority |