Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Bowel Prep

• Study Type: Interventional
• Enrollment (Actual): 519
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 38501
      • 301 Research Site 18
  • Arizona
    • Sun City, Arizona, United States, 85351
      • 301 Research Site 24
  • California
    • San Diego, California, United States, 92114
      • 301 Research Site 7
  • Florida
    • Clearwater, Florida, United States, 33756
      • 301 Research Site 16
    • Jacksonville, Florida, United States, 32216
      • 301 Research Site 12
    • Palm Harbor, Florida, United States, 34684
      • 301 Research Site 9
    • Palmetto Bay, Florida, United States, 33157
      • 301 Research Site 4
    • Port Orange, Florida, United States, 32127
      • 301 Research Site 26
    • Saint Petersburg, Florida, United States, 33709
      • 301 Research Site 14
    • Sunrise, Florida, United States, 33351
      • 301 Research Site 25
  • Georgia
    • Decatur, Georgia, United States, 30033
      • 301 Research Site 2
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • 301 Research Site 10
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • 301 Research Site 3
    • Shreveport, Louisiana, United States, 71105
      • 301 Research Site 17
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • 301 Research Site 11
  • Missouri
    • Chesterfield, Missouri, United States, 48047
      • 301 Research Site 13
  • Nevada
    • Reno, Nevada, United States, 89511
      • 301 Research Site 19
  • New York
    • Brooklyn, New York, United States, 11235
      • 301 Research Site 15
    • Great Neck, New York, United States, 11023
      • 301 Research Site 5
    • New York, New York, United States, 10033
      • 301 Research Site 23
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • 301 Research Site 6
  • Ohio
    • Mentor, Ohio, United States, 44060
      • 301 Research Site 21
  • Tennessee
    • Hixson, Tennessee, United States, 37434
      • 301 Research Site 20
  • Utah
    • Ogden, Utah, United States, 84405
      • 301 Research Site 1
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • 301 Research Site 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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.
• 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 inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
• Subjects who had previous significant gastrointestinal surgeries.
• Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
• 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.
• Subjects with uncontrolled hypertension.
• Subjects taking antibiotics within 7 days of colonoscopy.
• Subjects with severe renal, hepatic or cardiac insufficiency.
• 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 taking tricyclic antidepressants.
• Subjects using drugs of abuse, including abused prescription medications.
• Subjects who are withdrawing from alcohol or benzodiazepines.

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: BLI4900; Experimental bowel preparation solution for oral ingestion	Drug: Bowel Prep; Orally ingested liquid bowel preparation
Active Comparator: FDA Approved Control; FDA approved bowel preparation solution for oral ingestion	Drug: Bowel Prep; Orally ingested liquid bowel preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Successful Bowel Preparation	Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).	2 days

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: John McGowan, Braintree Laboratories / Sebela Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): December 22, 2020
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BLI4900-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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