Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUPREP Bowel Prep Kit | Experimental | SUPREP Bowel Prep Kit |
|
| FDA approved bowel preparation | Active Comparator | FDA approved bowel preparation containing electrolytes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUPREP Bowel Prep Kit | Drug | solution for oral administration prior to colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent") | Day of colonoscopy |
Not provided
Not provided
Inclusion Criteria:
Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
At least 18 years of age
If female, and of child-bearing potential, is using an acceptable form of birth control
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:
Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
Subjects who had previous significant gastrointestinal surgeries
Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on screening laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
Subjects with a prior history of renal, liver or cardiac insufficiency
Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
Subjects undergoing colonoscopy for foreign body removal and/or decompression.
Subjects who are pregnant or lactating, or intending to become pregnant during the study.
Subjects of childbearing potential who refuse a pregnancy test.
Subjects allergic to any preparation components.
Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
Subjects who withdraw consent before completion of Visit 1 procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John McGowan, MPH | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36693 | United States | ||
| Anaheim Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25028274 | Derived | Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SUPREP Bowel Prep Kit | SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy |
| FG001 | FDA Approved Bowel Preparation | FDA approved bowel preparation containing electrolytes FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FDA approved bowel preparation containing electrolytes |
| Drug |
solution for oral administration prior to colonoscopy |
|
| Anaheim |
| California |
| 92801 |
| United States |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| Commonwealth Clinical Studies | Brockton | Massachusetts | 02302 | United States |
| Gastrointestinal Associates | Jackson | Mississippi | 39202 | United States |
| Long Island GI Research Group | Great Neck | New York | 11023 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Northwest Gastroenterology Clinic | Portland | Oregon | 97210 | United States |
| Franklin Gastroenterology | Franklin | Tennessee | 37067 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Participants represents the population that was dispensed a preparation and took any portion of the preparation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SUPREP Bowel Prep Kit | SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy |
| BG001 | FDA Approved Bowel Preparation | FDA approved bowel preparation containing electrolytes FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | lbs |
|
| 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 | Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent") | The analysis population contains subjects that consumed any portion of their bowel preparation. Subject who discontinued from the study for reasons other safety of efficacy are not included (e.g. insurance issues). | Posted | Number | percentage of subjects | Day of colonoscopy |
|
|
|
Treatment emergent adverse events were collected for Preparation Day 1 and Day 2 (Day of Colonoscopy). Serious adverse events were collected for a period of 30 days.
Adverse events for stomach cramping, stomach bloating and nausea were documented only if the symptom required an intervention or resulted in discontinuation of the bowel preparation.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SUPREP Bowel Prep Kit | SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy | 0 | 169 | 0 | 169 | ||
| EG001 | FDA Approved Bowel Preparation | FDA approved bowel preparation containing electrolytes FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy | 2 | 169 | 0 | 169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| cholecystitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| bile duct stone | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
Not provided
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 extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John McGowan, Director Clinical Research | Braintree Laboratories, Inc. | 781-843-2202 | jmcgowan@braintreelabs.com |
| Male |
|