A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 4/17/2018 |
Start Date: | August 8, 2017 |
End Date: | March 26, 2018 |
The objective of this study is to compare the safety and efficacy of BLI4700 bowel
preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations
prior to colonoscopy in adult patients.
preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations
prior to colonoscopy in adult patients.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
We found this trial at
18
sites
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