A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Braintree Laboratories

Status and phase

Completed

Phase 2

Conditions

Colonoscopy

Treatments

Drug: BLI4900

Drug: PEG Control

Study type

Interventional

Funder types

Industry

Identifiers

NCT03328507

BLI4900-201

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.

Enrollment

121 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.