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

NCT03261960 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BLI4700-302
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 20

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Subjects With Successful Bowel Cleansing

  % of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)

  Day of colonoscopy

Other Outcomes (4)

• Abdominal Pain (Solicited Reports)

  2 days

• Abdominal Distension (Solicited Reports)

  2 days

• Nausea (Solicited Reports)

  2 days

Study Arms (2)

Experimental Arm

EXPERIMENTAL

BLI4700 Bowel Preparation

Drug: BLI4700

Control Arm

ACTIVE COMPARATOR

FDA Approved Bowel Preparation

Drug: Magnesium bowel preparation

Interventions

BLI4700 DRUG

Oral bowel preparation

Experimental Arm

Magnesium bowel preparation DRUG

Oral bowel preparation

Control Arm

Eligibility Criteria

• Age: 18 Years - 85 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.
• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (20)

Braintree Research Site 119

Dothan, Alabama, 36305, United States

Location

Braintree Research Site 117

Tucson, Arizona, 85710, United States

Location

Braintree Research Site 108

Little Rock, Arkansas, 72117, United States

Location

Braintree Research Site 110

Little Rock, Arkansas, 72211, United States

Location

Braintree Research Site 139

Palmetto Bay, Florida, 33157, United States

Location

Braintree Research Site 124

Oak Lawn, Illinois, 60453, United States

Location

Braintree Research Site 134

Indianapolis, Indiana, 46202, United States

Location

Braintree Research Site 112

Chevy Chase, Maryland, 20815, United States

Location

Braintree Research Site 141

Towson, Maryland, 20214, United States

Location

Braintree Research Site 125

Chesterfield, Missouri, 48047, United States

Location

Braintree Research Site 102

St Louis, Missouri, 63128, United States

Location

Braintree Research Site 145

Egg Harbor, New Jersey, 08234, United States

Location

Braintree Research Site 114

Poughkeepsie, New York, 12601, United States

Location

Braintree Research Site 105

Asheville, North Carolina, 28801, United States

Location

Braintree Research Site 115

Charlotte, North Carolina, 28207, United States

Location

Braintree Research Site 137

Raleigh, North Carolina, 27607, United States

Location

Braintree Research Site 101

Raleigh, North Carolina, 27612, United States

Location

Braintree Research Site 107

Greenville, South Carolina, 29615, United States

Location

Braintree Research Site 131

Charlottesville, Virginia, 22911, United States

Location

Braintree Research Site 121

Bellevue, Washington, 98004, United States

Location

Results Point of Contact

• Title: Head of R&D, Gastroenterology
• Organization: Braintree Laboratories, Inc.

studydirector@sebelapharma.com

781-843-2202

Study Officials

• John McGowan, MPH

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: August 8, 2017
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: September 8, 2021
• Results First Posted: September 8, 2021

Record last verified: 2021-08

Locations

US (20)