A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing Colonoscopy
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/20/2016 |
Start Date: | January 2015 |
End Date: | June 2015 |
To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a
bowel preparation prior to colonoscopy in adult patients.
bowel preparation prior to colonoscopy in adult patients.
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.
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University of South Alabama "University of South Alabama is a public institution that was founded...
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