A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Phase 3

Completed

• Conditions: Colonoscopy
• Interventions: Drug: BLI4700; Drug: Magnesium bowel preparation

• Registration Number: NCT03261960
• Lead Sponsor: Braintree Laboratories

Brief Summary

The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-08
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Disposition First Submitted: 2019-09-27
• Results First Submitted: 2021-05-04
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-12
• Disposition First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Results First Posted: 2021-09-08
• Disposition First Posted: 2021-09-08
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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 serum 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, gastrointestinal obstruction, gastroparesis, 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 taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain is not exclusionary.
• Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg).
• Subjects taking antibiotics within 7 days of colonoscopy.
• 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 with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
• 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 component.
• Subjects using drugs of abuse, including abused prescription medications.
• Subjects who are withdrawing from alcohol or benzodiazepines.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	BLI4700	BLI4700 Bowel Preparation
Control Arm	Magnesium bowel preparation	FDA Approved Bowel Preparation

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Subjects With Successful Bowel Cleansing	Day of colonoscopy	% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)

Trial Locations

Locations (20)

Braintree Research Site 112; 🇺🇸 Chevy Chase, Maryland, United States

Braintree Research Site 102; 🇺🇸 Saint Louis, Missouri, United States

Braintree Research Site 105; 🇺🇸 Asheville, North Carolina, United States

Braintree Research Site 101; 🇺🇸 Raleigh, North Carolina, United States

Braintree Research Site 145; 🇺🇸 Egg Harbor Township, New Jersey, United States

Braintree Research Site 139; 🇺🇸 Palmetto Bay, Florida, United States

Braintree Research Site 115; 🇺🇸 Charlotte, North Carolina, United States

Braintree Research Site 131; 🇺🇸 Charlottesville, Virginia, United States

Braintree Research Site 117; 🇺🇸 Tucson, Arizona, United States

Braintree Research Site 119; 🇺🇸 Dothan, Alabama, United States

Braintree Research Site 108; 🇺🇸 Little Rock, Arkansas, United States

Braintree Research Site 110; 🇺🇸 Little Rock, Arkansas, United States

Braintree Research Site 141; 🇺🇸 Towson, Maryland, United States

Braintree Research Site 125; 🇺🇸 Chesterfield, Missouri, United States

Braintree Research Site 114; 🇺🇸 Poughkeepsie, New York, United States

Braintree Research Site 107; 🇺🇸 Greenville, South Carolina, United States

Braintree Research Site 121; 🇺🇸 Bellevue, Washington, United States

Braintree Research Site 124; 🇺🇸 Oak Lawn, Illinois, United States

Braintree Research Site 137; 🇺🇸 Raleigh, North Carolina, United States

Braintree Research Site 134; 🇺🇸 Indianapolis, Indiana, United States