A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-09

Study Completion Date

2019-11-12

Brief Summary

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

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Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BLI4900

BLI4900 Bowel Preparation

Group Type EXPERIMENTAL

BLI4900

Intervention Type DRUG

BLI4900 Bowel Preparation

PEG Control

Polyethylene glycol-based bowel preparation

Group Type ACTIVE_COMPARATOR

PEG Control

Intervention Type DRUG

Polyethylene glycol-based bowel preparation

Interventions

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BLI4900

BLI4900 Bowel Preparation

Intervention Type DRUG

PEG Control

Polyethylene glycol-based bowel preparation

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No