The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel
preparation prior to colonoscopy in adult patients.
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Locations near you
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Full eligibility criteria for NCT03023085
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
Have previously had a colonoscopy performed
At least 18 years of age
Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)
If female, and of child-bearing potential, is using an acceptable form of birth control.
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 Key
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.
Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
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.
All locations for NCT03023085
United States (1)
Braintree Research Site 1
Anaheim, California, United States
View full eligibility
Tris trial is registered with FDA with number: NCT03023085. The sponsor of the trial is Braintree Laboratories and it is looking for 120 volunteers for the current phase.
Official trial title: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
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