A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing Colonoscopy

NCT ID: NCT02376465

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-06-30

Brief Summary

To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a bowel preparation prior to colonoscopy in adult patients.

Conditions

Bowel Preparation for Colonoscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BLI4600 Regimen 1

Oral bowel preparation for colonoscopy

Group Type: EXPERIMENTAL

BLI4600 bowel preparation

Intervention Type: DRUG

Oral bowel preparation for colonoscopy

BLI4600 Regimen 2

Oral bowel preparation for colonoscopy

Group Type: EXPERIMENTAL

BLI4600 bowel preparation

Intervention Type: DRUG

Oral bowel preparation for colonoscopy

PEG based below preparation

Oral bowel preparation for colonoscopy

Group Type: ACTIVE_COMPARATOR

PEG based bowel preparation

Intervention Type: DRUG

Oral bowel preparation for colonoscopy

Interventions

BLI4600 bowel preparation

Oral bowel preparation for colonoscopy

Intervention Type: DRUG

PEG based bowel preparation

Oral bowel preparation for colonoscopy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication

At least 18 years of age

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 who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass, stomach stapling).

Subjects with uncontrolled pre-existing electrolyte abnormalities, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

Subjects with a prior history of renal, liver or cardiac insufficiency.

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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John McGowan, MPH

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

University of South Alabama

Mobile, Alabama, United States

Countries

United States

Other Identifiers

BLI4600-201

Identifier Type: -

Identifier Source: org_study_id