Bowel Preparation, Colonoscopy, Endoscopy
Conditions
Brief summary
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.
Interventions
solution for oral administration prior to colonoscopy
DRUGFDA approved bowel preparation containing electrolytes
solution for oral administration prior to colonoscopy
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Subjects With a Successful Preparation (Cleaning Rated as Good or Excellent) | Day of colonoscopy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit
SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy | 169 |
| FDA Approved Bowel Preparation FDA approved bowel preparation containing electrolytes
FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy | 169 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 4 |
Baseline characteristics
| Characteristic | Total | SUPREP Bowel Prep Kit | FDA Approved Bowel Preparation |
|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 10 | 57.9 years STANDARD_DEVIATION 10.4 | 57.8 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 338 participants | 169 participants | 169 participants |
| Sex: Female, Male Female | 187 Participants | 94 Participants | 93 Participants |
| Sex: Female, Male Male | 151 Participants | 75 Participants | 76 Participants |
| Weight | 190 lbs STANDARD_DEVIATION 45 | 188 lbs STANDARD_DEVIATION 39 | 192 lbs STANDARD_DEVIATION 49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 169 | 0 / 169 |
| serious Total, serious adverse events | 0 / 169 | 2 / 169 |
Outcome results
Primary
Percentage of Subjects With a Successful Preparation (Cleaning Rated as Good or Excellent)
Time frame: Day of colonoscopy
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SUPREP Bowel Prep Kit | Percentage of Subjects With a Successful Preparation (Cleaning Rated as Good or Excellent) | 95 percentage of subjects |
| FDA Approved Bowel Preparation | Percentage of Subjects With a Successful Preparation (Cleaning Rated as Good or Excellent) | 86 percentage of subjects |