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The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | BLI4700 Bowel Preparation |
|
| Control Arm | Active Comparator | FDA Approved Bowel Preparation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI4700 | Drug | Oral bowel preparation |
| |
| Magnesium bowel preparation |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects With Successful Bowel Cleansing | % of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent) | Day of colonoscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Pain (Solicited Reports) | Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event. | 2 days |
| Abdominal Distension (Solicited Reports) |
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 |
|---|---|---|---|---|---|---|
| Braintree Research Site 119 | Dothan | Alabama | 36305 | United States | ||
| Braintree Research Site 117 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Arm | BLI4700 Bowel Preparation BLI4700: Oral bowel preparation |
| FG001 | Control Arm | FDA Approved Bowel Preparation Magnesium bowel preparation: Oral 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 | Jul 28, 2017 |
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| Drug |
Oral bowel preparation |
|
Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
| 2 days |
| Nausea (Solicited Reports) | Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event. | 2 days |
| Vomiting (Solicited Reports) | Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event. | 2 days |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Braintree Research Site 108 | Little Rock | Arkansas | 72117 | United States |
| Braintree Research Site 110 | Little Rock | Arkansas | 72211 | United States |
| Braintree Research Site 139 | Palmetto Bay | Florida | 33157 | United States |
| Braintree Research Site 124 | Oak Lawn | Illinois | 60453 | United States |
| Braintree Research Site 134 | Indianapolis | Indiana | 46202 | United States |
| Braintree Research Site 112 | Chevy Chase | Maryland | 20815 | United States |
| Braintree Research Site 141 | Towson | Maryland | 20214 | United States |
| Braintree Research Site 125 | Chesterfield | Missouri | 48047 | United States |
| Braintree Research Site 102 | St Louis | Missouri | 63128 | United States |
| Braintree Research Site 145 | Egg Harbor | New Jersey | 08234 | United States |
| Braintree Research Site 114 | Poughkeepsie | New York | 12601 | United States |
| Braintree Research Site 105 | Asheville | North Carolina | 28801 | United States |
| Braintree Research Site 115 | Charlotte | North Carolina | 28207 | United States |
| Braintree Research Site 137 | Raleigh | North Carolina | 27607 | United States |
| Braintree Research Site 101 | Raleigh | North Carolina | 27612 | United States |
| Braintree Research Site 107 | Greenville | South Carolina | 29615 | United States |
| Braintree Research Site 131 | Charlottesville | Virginia | 22911 | United States |
| Braintree Research Site 121 | Bellevue | Washington | 98004 | United States |
|
| COMPLETED |
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| NOT COMPLETED |
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Safety population - all patients that took preparation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm | BLI4700 Bowel Preparation BLI4700: Oral bowel preparation |
| BG001 | Control Arm | FDA Approved Bowel Preparation Magnesium bowel preparation: Oral bowel preparation |
| BG002 | 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 |
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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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| 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 | Number | participants |
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| Renal Insufficiency (GFR < 60) | Subjects with baseline GFR < 60 mL/min/1.73 m2 | Count of Participants | Participants |
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| Diabetic | Subjects with a medical history of diabetes | 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 | Number and Percentage of Subjects With Successful Bowel Cleansing | % of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent) | Efficacy population | Posted | Count of Participants | Participants | Day of colonoscopy |
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| Other Pre-specified | Abdominal Pain (Solicited Reports) | Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event. | Posted | Number | percentage of patients | 2 days |
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| Other Pre-specified | Abdominal Distension (Solicited Reports) | Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event. | Posted | Number | percentage of patients | 2 days |
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| Other Pre-specified | Nausea (Solicited Reports) | Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event. | Posted | Number | percentage of patients | 2 days |
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| Other Pre-specified | Vomiting (Solicited Reports) | Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event. | Posted | Number | percentage of patients | 2 days |
|
|
30 days
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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 | Experimental Arm | BLI4700 Bowel Preparation BLI4700: Oral bowel preparation | 0 | 190 | 0 | 190 | 5 | 190 |
| EG001 | Control Arm | FDA Approved Bowel Preparation Magnesium bowel preparation: Oral bowel preparation | 0 | 199 | 1 | 199 | 2 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver function test increased | Investigations | 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, Gastroenterology | Braintree Laboratories, Inc. | 781-843-2202 | studydirector@sebelapharma.com |
| Apr 30, 2021 |
| Prot_SAP_000.pdf |
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| >=65 years |
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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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