This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
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.
Locations (10)
Unnamed facility
Anaheim, California, United States
Unnamed facility
Orange, California, United States
Unnamed facility
Jackson, Mississippi, United States
Unnamed facility
Portland, Oregon, United States
Outcomes
Primary Outcomes
Efficacy - preparation quality using a 4 point scale
Time frame: 2-Day
Secondary Outcomes
Safety-preparation related side effects; laboratory analysis