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

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

Study Overview

• Status: Completed
• Conditions: Bowel Preparation for Colonoscopy
• Intervention / Treatment: Drug: BLI4600 bowel preparation; Drug: PEG based bowel preparation

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • University of South Alabama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI4600 Regimen 1; Oral bowel preparation for colonoscopy	Drug: BLI4600 bowel preparation; Oral bowel preparation for colonoscopy
Experimental: BLI4600 Regimen 2; Oral bowel preparation for colonoscopy	Drug: BLI4600 bowel preparation; Oral bowel preparation for colonoscopy
Active Comparator: PEG based below preparation; Oral bowel preparation for colonoscopy	Drug: PEG based bowel preparation; Oral bowel preparation for colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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 Outcome Measures

Outcome Measure	Time Frame
Ottawa Bowel Preparation Scale Score	1 Day

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BLI4600-201