Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Braintree Laboratories
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
18 to 85 years of age (inclusive)
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 serum pregnancy test at screening, if applicable
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
You may not be if
Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
Subjects with ongoing severe, acute inflammatory bowel disease
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 taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain is not exclusionary.
Subjects with uncontrolled hypertension (systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 100 mmHg).
Subjects taking antibiotics within 7 days of colonoscopy.
Subjects with severe renal insufficiency (GFR \< 30 mL/min/1.73m2).
Subjects with known severe hepatic insufficiency (Child Pugh C)
Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).
Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
Subjects undergoing insulin therapy for any indication.
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 component.
Subjects using drugs of abuse, including abused prescription medications.
Subjects who are withdrawing from alcohol or benzodiazepines.
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.
Clareo Health | A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
