Bowel Preparation for Colonoscopy
Conditions
Brief summary
To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a bowel preparation prior to colonoscopy in adult patients.
Interventions
DRUGBLI4600 bowel preparation
Oral bowel preparation for colonoscopy
DRUGPEG based bowel preparation
Oral bowel preparation for colonoscopy
Sponsors
Braintree Laboratories
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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 (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
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 (e.g. colostomy, colectomy, gastric bypass, stomach stapling). Subjects with uncontrolled pre-existing electrolyte abnormalities, 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 | Description |
|---|---|---|
| % of subjects with successful preparation on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent) | 1 Day | % of subjects with successful preparation by colonoscopist on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent) |
Secondary
| Measure | Time frame |
|---|---|
| Ottawa Bowel Preparation Scale Score | 1 Day |
Countries
United States
Outcome results
None listed