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| ID | Type | Description | Link |
|---|---|---|---|
| BLI850-301 |
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This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | multi-dose preparation for oral administration prior to colonoscopy |
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| 2 | Active Comparator | multi-dose preparation for oral administration prior to colonoscopy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI850 | Drug | multi-dose preparation for oral administration prior to colonoscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Preparation Quality Using a 4 Point Scale | Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent" | 2-day |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Chemistry Results (mg/dL) | Change from Baseline | 2 days |
| Hematology Results (%) | Change from Baseline | 2 days |
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Inclusion Criteria:
Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:
At least 18 years of age.
Otherwise in good health, as determined by physical exam and medical history.
If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
Negative urine pregnancy test at screening, if applicable.
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D McGowan | Braintree Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36693 | United States | ||
| Jupiter Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI850 | Single administration oral preparation |
| FG001 | Polyethylene Glycol 3350 Based Bowel Preparation | Single administration oral preparation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| polyethylene glycol 3350 based bowel preparation |
| Drug |
multi-dose preparation for oral administration prior to colonoscopy |
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| Serum Chemistry Results (U/L) | Change from Baseline | 2 days |
| Serum Chemistry Results (mEq/L) | Change from Baseline | 2 days |
| Serum Chemistry Results (g/dL) | Change from Baseline | 2 days |
| Serum Chemistry Results (GFR) | Change from Baseline | 2 days |
| Hematology Results (1000/MCL) | Change from Baseline | 2 days |
| Hematology Results - Hemoglobin | Change from Baseline | 2 days |
| Hematology Results - Red Blood Cells | Change from Baseline | 2 days |
| Serum Chemistry Results (Osmolality) | Change from Baseline | 2 days |
| Jupiter |
| Florida |
| 33458 |
| United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| United Medical Research | New Smyrna Beach | Florida | 32168 | United States |
| Atlanta Gastroenterology Associates | Roswell | Georgia | 30076 | United States |
| Delta Research Partners | Monroe | Louisiana | 71201 | United States |
| Maryland Digestive Disease Research | Laurel | Maryland | 20707 | United States |
| Long Island GI Research Group | Great Neck | New York | 11023 | United States |
| Carolina Digestive Health Associates | Harrisburg | North Carolina | 28075 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Regional Gastroenterology Associates of Lancaster | Lancaster | Pennsylvania | 17604 | United States |
| Southeastern Clinical Research | Chattanooga | Tennessee | 37403 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI850 | |
| BG001 | Polyethylene Glycol 3350 Based 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, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Efficacy - Preparation Quality Using a 4 Point Scale | Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent" | Posted | Number | 95% Confidence Interval | percentage of participants | 2-day |
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| Secondary | Serum Chemistry Results (mg/dL) | Change from Baseline | Intent-to-treat population: all patients that took any portion of the study preparation. | Posted | Mean | Standard Deviation | mg/dL | 2 days |
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| Secondary | Hematology Results (%) | Change from Baseline | Intent to treat population | Posted | Mean | Standard Deviation | standard % | 2 days |
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| Secondary | Serum Chemistry Results (U/L) | Change from Baseline | Intent-to-treat population: all patients that took any portion of the study preparation. | Posted | Mean | Standard Deviation | U/L | 2 days |
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| Secondary | Serum Chemistry Results (mEq/L) | Change from Baseline | Intent-to-treat population: all patients that took any portion of the study preparation. | Posted | Mean | Standard Deviation | mEq/L | 2 days |
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| Secondary | Serum Chemistry Results (g/dL) | Change from Baseline | Intent-to-treat population: all patients that took any portion of the study preparation. | Posted | Mean | Standard Deviation | g/dL | 2 days |
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| Secondary | Serum Chemistry Results (GFR) | Change from Baseline | Posted | Mean | Standard Deviation | ml/min | 2 days |
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| Secondary | Hematology Results (1000/MCL) | Change from Baseline | Intent to treat population | Posted | Mean | Standard Deviation | 1000/MCL | 2 days |
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| Secondary | Hematology Results - Hemoglobin | Change from Baseline | Posted | Mean | Standard Deviation | g/dL | 2 days |
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| Secondary | Hematology Results - Red Blood Cells | Change from Baseline | Posted | Mean | Standard Deviation | MILL/MCL | 2 days |
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| Secondary | Serum Chemistry Results (Osmolality) | Change from Baseline | Posted | Mean | Standard Deviation | mOsm/kg | 2 days |
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2 days
ITT Population - all subjects that took any portion of preparation
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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 | BLI850 | 0 | 176 | 145 | 176 | |||
| EG001 | Polyethylene Glycol 3350 Based Bowel Preparation | 0 | 190 | 142 | 190 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| overall discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 360 days from the time submitted to the sponsor for review. The sponsor cannot extent the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John McGowan | Braintree Laboratories | 781-843-2202 | jmcgowan@braintreelabs.com |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| >=65 years |
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| Male |
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