Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

NCT04446312 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BLI4900-302
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 34

Brief Summary

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

BLI4900

EXPERIMENTAL

Experimental bowel preparation solution for oral ingestion

Drug: Bowel Prep

FDA Approved Control

ACTIVE COMPARATOR

FDA approved bowel preparation solution for oral ingestion

Drug: Bowel Prep

Interventions

Bowel Prep DRUG

Orally ingested liquid bowel preparation

BLI4900; FDA Approved Control

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.
• 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 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (34)

302 Research Site 2

Tucson, Arizona, 85712, United States

Location

302 Research Site 10

Little Rock, Arkansas, 72211, United States

Location

302 Research Site 11

North Little Rock, Arkansas, 72117, United States

Location

302 Research Site 9

Chula Vista, California, 91910, United States

Location

302 Research Site 31

Los Angeles, California, 90036, United States

Location

302 Research Site 22

Bristol, Connecticut, 06010, United States

Location

302 Research Site 17

Fleming Island, Florida, 32003, United States

Location

302 Research Site 3

Inverness, Florida, 34452, United States

Location

302 Research Site 14

Jacksonville, Florida, 32256, United States

Location

302 Research Site 28

Miami, Florida, 33134, United States

Location

302 Research Site 29

Miami, Florida, 33155, United States

Location

302 Research Site 30

Miami, Florida, 33155, United States

Location

302 Research Site 38

Palm Harbor, Florida, 34684, United States

Location

302 Research Site 5

Oak Lawn, Illinois, 60453, United States

Location

302 Research Site 34

Baton Rouge, Louisiana, 70809, United States

Location

302 Research Site 26

Mandeville, Louisiana, 70471, United States

Location

302 Research Site 36

Monroe, Louisiana, 71201, United States

Location

302 Research Site 16

Hagerstown, Maryland, 21742, United States

Location

302 Research Site 39

Brooklyn, New York, 11235, United States

Location

302 Research Site 37

Great Neck, New York, 11023, United States

Location

302 Research Site 8

Asheville, North Carolina, 28801, United States

Location

302 Research Site 25

High Point, North Carolina, 27262, United States

Location

302 Research Site 1

Raleigh, North Carolina, 27612, United States

Location

302 Research Site 13

Wilmington, North Carolina, 28403, United States

Location

302 Research Site 18

Cincinnati, Ohio, 45219, United States

Location

302 Research Site 23

Jackson, Tennessee, 38305, United States

Location

302 Research Site 33

Kingsport, Tennessee, 37660, United States

Location

302 Research Site 32

Cedar Park, Texas, 78613, United States

Location

302 Research Site 21

Houston, Texas, 77058, United States

Location

302 Research Site 35

Southlake, Texas, 76092, United States

Location

302 Research Site 27

Webster, Texas, 77598, United States

Location

302 Research Site 6

Charlottesville, Virginia, 22911, United States

Location

302 Research Site 4

Fairfax, Virginia, 22031, United States

Location

302 Research Site 7

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• Bhandari R, Goldstein M, Mishkin DS, McGowan J, Cleveland MV, Di Palma JA. Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy. J Clin Gastroenterol. 2023 Oct 1;57(9):920-927. doi: 10.1097/MCG.0000000000001894.

  PMID: 37490604 DERIVED

Results Point of Contact

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

studydirector@sebelapharma.com

781-843-2202

Study Officials

• John McGowan

  Braintree Laboratories / Sebela Pharmaceuticals

  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: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 13, 2020
• Primary Completion: January 7, 2021
• Study Completion: February 5, 2021
• Last Updated: October 27, 2023
• Results First Posted: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)