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

Phase 2

Completed

• Conditions: Bowel Preparation for Colonoscopy
• Interventions: Drug: PEG based bowel preparation; Drug: BLI4600 bowel preparation

• Registration Number: NCT02376465
• Lead Sponsor: Braintree Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-07
• Disposition First Submitted: 2016-07-18
• Disposition First Submitted QC: 2016-07-18
• Last Update Submitted: 2016-07-18
• Disposition First Posted: 2016-07-19
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG based below preparation	PEG based bowel preparation	Oral bowel preparation for colonoscopy
BLI4600 Regimen 1	BLI4600 bowel preparation	Oral bowel preparation for colonoscopy
BLI4600 Regimen 2	BLI4600 bowel preparation	Oral bowel preparation for colonoscopy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ottawa Bowel Preparation Scale Score	1 Day

Trial Locations

Locations (1)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States