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.
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 inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
Subjects who had previous significant gastrointestinal surgeries.
Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
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.
Subjects with uncontrolled hypertension.
Subjects taking antibiotics within 7 days of colonoscopy.
Subjects with severe renal, hepatic or cardiac insufficiency.
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 taking tricyclic antidepressants.
Subjects using drugs of abuse, including abused prescription medications.
Subjects who are withdrawing from alcohol or benzodiazepines.
Clareo Health | Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
