Colonoscopy
Conditions
Keywords
colonoscopy, bowel preparation, prep
Brief summary
This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
Interventions
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE
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, including: * Evaluation of BE results * GI bleeding * Anemia of unknown etiology * Neoplastic disease surveillance * Endosonography * Inflammatory bowel disease * Unknown diarrhea or constipation etiology * Polypectomy * Laser therapy * Routine Screening * At least 18 years of age * Otherwise in good health, as determined by physical exam and medical history * 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 with impaired consciousness that predisposes them to pulmonary aspiration. * Subjects who are undergoing colonoscopy for foreign body removal and decompression. * Subjects with clinically significant electrolyte abnormalities based on Visit 1 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 history of renal or hepatic insufficiency or congestive heart failure. * Subjects who had previous gastrointestinal surgeries * Subjects who are pregnant or lactating, or intending to become pregnant during the study. * Subjects of childbearing potential who refuse a pregnancy test. * Subjects who are 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 clinical, surgical, drug, or device study within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - preparation quality using a 4 point scale | 2-Day |
Secondary
| Measure | Time frame |
|---|---|
| Safety - preparation related side effects; laboratory analysis | 30-Day |
Countries
United States
Outcome results
None listed