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

NCT02376465 | Completed Phase 2

• 1 other identifier: BLI4600-201
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• % of subjects with successful preparation on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent)

  % of subjects with successful preparation by colonoscopist on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent)

  1 Day

Secondary Outcomes (1)

• Ottawa Bowel Preparation Scale Score

  1 Day

Study Arms (3)

BLI4600 Regimen 1

EXPERIMENTAL

Oral bowel preparation for colonoscopy

Drug: BLI4600 bowel preparation

BLI4600 Regimen 2

EXPERIMENTAL

Oral bowel preparation for colonoscopy

Drug: BLI4600 bowel preparation

PEG based below preparation

ACTIVE COMPARATOR

Oral bowel preparation for colonoscopy

Drug: PEG based bowel preparation

Interventions

BLI4600 bowel preparation DRUG

Oral bowel preparation for colonoscopy

BLI4600 Regimen 1; BLI4600 Regimen 2

PEG based bowel preparation DRUG

Oral bowel preparation for colonoscopy

PEG based below preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (1)

University of South Alabama

Mobile, Alabama, 36693, United States

Location

Study Officials

• John McGowan, MPH

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 3, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

US (1)