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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 |
|---|---|---|---|
| BLI4700 Bowel Preparation | Experimental |
| |
| FDA Approved Bowel Preparation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI4700 | Drug | Oral bowel preparation |
| |
| Polyethylene glycol 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 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 | 2 days |
| Abdominal Pain (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 212 | Mobile | Alabama | 36688 | United States | ||
| Braintree Research Site 204 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33165006 | Derived | Di Palma JA, Bhandari R, Cleveland MV, Mishkin DS, Tesoriero J, Hall S, McGowan J. A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy. Am J Gastroenterol. 2021 Feb 1;116(2):319-328. doi: 10.14309/ajg.0000000000001020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI4700 Bowel Preparation | BLI4700: Oral bowel preparation |
| FG001 | FDA Approved Bowel Preparation | Polyethylene glycol 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 | Apr 5, 2018 |
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| Drug |
Oral bowel preparation |
|
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 |
| 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 |
| 85712 |
| United States |
| Braintree Research Site 209 | Anaheim | California | 92801 | United States |
| Braintree Research Site 219 | Chula Vista | California | 91910 | United States |
| Braintree Research Site 206 | Los Angeles | California | 90045 | United States |
| Braintree Research Site 220 | San Diego | California | 92114 | United States |
| Braintree Research Site 221 | Inverness | Florida | 34452 | United States |
| Braintree Research Site 222 | Jacksonville | Florida | 32216 | United States |
| Braintree Research Site 201 | Palm Harbor | Florida | 34684 | United States |
| Braintree Research Site 224 | Atlanta | Georgia | 30342 | United States |
| Braintree Research Site 215 | Decatur | Georgia | 30033 | United States |
| Braintree Research Site 223 | Lake Charles | Louisiana | 70601 | United States |
| Braintree Research Site 211 | Monroe | Louisiana | 71201 | United States |
| Braintree Research Site 207 | Hagerstown | Maryland | 21742 | United States |
| Braintree Research Site 218 | Flowood | Mississippi | 39232 | United States |
| Braintree Research Site 210 | Great Neck | New York | 11023 | United States |
| Braintree Research Site 214 | Cincinnati | Ohio | 45219 | United States |
| Braintree Research Site 213 | Portland | Oregon | 97210 | United States |
| Braintree Research Site 216 | Columbia | South Carolina | 29203 | United States |
| Braintree Research Site 202 | Franklin | Tennessee | 37067 | United States |
| Braintree Research Site 203 | Jackson | Tennessee | 38305 | United States |
| Braintree Research Site 217 | Ogden | Utah | 84405 | United States |
| Braintree Research Site 208 | Milwaukee | Wisconsin | 53215 | United States |
|
| COMPLETED |
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| NOT COMPLETED |
|
safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI4700 Bowel Preparation | BLI4700: Oral bowel preparation |
| BG001 | FDA Approved Bowel Preparation | Polyethylene glycol 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 |
| ||||||||||||||||||
| 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 |
| ||||||||||||||||||
| Diabetic | Subjects with medical history of diabetes | Count of Participants | Participants |
| |||||||||||||||||
| Renal Insufficiency (GFR < 60) | Subjects with baseline GFR < 60 mL/min/1.73 m2 | 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 | 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 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 | 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 | 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 | BLI4700 Bowel Preparation | BLI4700: Oral bowel preparation | 0 | 281 | 0 | 281 | 1 | 281 |
| EG001 | FDA Approved Bowel Preparation | Polyethylene glycol bowel preparation: Oral bowel preparation | 0 | 271 | 2 | 271 | 4 | 271 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| escherichia sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| pyelonephritis acute | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | 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, 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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