NCT03328507CompletedPhase 2
A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Braintree Laboratories4 sites in 1 country121 target enrollmentStarted: November 9, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 121
- Locations
- 4
- Primary Endpoint
- % of Subjects With Successful Bowel Preparation
Study Overview
Brief Summary
The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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.
Exclusion Criteria
- •Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, 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 with uncontrolled hypertension (systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg).
- •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 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 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.
- •Subjects who withdraw consent before completion of Visit 1 procedures.
Arms & Interventions
BLI4900
Experimental
BLI4900 Bowel Preparation
Intervention: BLI4900 (Drug)
PEG Control
Active Comparator
Polyethylene glycol-based bowel preparation
Intervention: PEG Control (Drug)
Outcomes
Primary Outcomes
% of Subjects With Successful Bowel Preparation
Time Frame: Day of colonoscopy
% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
Loading locations...
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