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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: BLI4700; Drug: Magnesium bowel preparation

• Study Type: Interventional
• Enrollment (Actual): 389
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Braintree Research Site 119
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Braintree Research Site 117
  • Arkansas
    • Little Rock, Arkansas, United States, 72117
      • Braintree Research Site 108
    • Little Rock, Arkansas, United States, 72211
      • Braintree Research Site 110
  • Florida
    • Palmetto Bay, Florida, United States, 33157
      • Braintree Research Site 139
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Braintree Research Site 124
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Braintree Research Site 134
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Braintree Research Site 112
    • Towson, Maryland, United States, 20214
      • Braintree Research Site 141
  • Missouri
    • Chesterfield, Missouri, United States, 48047
      • Braintree Research Site 125
    • Saint Louis, Missouri, United States, 63128
      • Braintree Research Site 102
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • Braintree Research Site 145
  • New York
    • Poughkeepsie, New York, United States, 12601
      • Braintree Research Site 114
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Braintree Research Site 105
    • Charlotte, North Carolina, United States, 28207
      • Braintree Research Site 115
    • Raleigh, North Carolina, United States, 27607
      • Braintree Research Site 137
    • Raleigh, North Carolina, United States, 27612
      • Braintree Research Site 101
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Braintree Research Site 107
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Braintree Research Site 131
  • Washington
    • Bellevue, Washington, United States, 98004
      • Braintree Research Site 121

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (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.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; BLI4700 Bowel Preparation	Drug: BLI4700; Oral bowel preparation
Active Comparator: Control Arm; FDA Approved Bowel Preparation	Drug: Magnesium bowel preparation; Oral bowel preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Pain (Solicited Reports)	Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.	2 days
Abdominal Distension (Solicited Reports)	Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.	2 days
Nausea (Solicited Reports)	Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.	2 days
Vomiting (Solicited Reports)	Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.	2 days

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): March 26, 2018
• Study Completion (Actual): March 26, 2018

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BLI4700-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No