Expired Study
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Mobile, Alabama 36693


Purpose:

To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a bowel preparation prior to colonoscopy in adult patients.


Criteria:

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.


NCT ID:

NCT02376465


Primary Contact:

Study Director
John McGowan, MPH
Braintree Laboratories, Inc.


Backup Contact:

N/A


Location Contact:

Mobile, Alabama 36693
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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