The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.
- Drug: BLI4700BLI4700 bowel preparation
|Ages eligible for Study||18 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- 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.
United States (1)
- Braintree Research Site 1recruitingAnaheim, California, United States
31 July, 2016
12 January, 2017