A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

NCT02819323 | Completed Phase 3 Results

• 1 other identifier: BLI800-502
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 27

Brief Summary

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Subjects With Successful Bowel Cleansing

  Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)

  2 days

Study Arms (3)

BLI800 high dose

EXPERIMENTAL

BLI800 bowel preparation (high dose)

Drug: BLI800

BLI800 low dose

EXPERIMENTAL

BLI800 bowel preparation (low dose)

Drug: BLI800

PEG-ELS

ACTIVE COMPARATOR

PEG based bowel preparation

Drug: PEG-ELS

Interventions

PEG-ELS DRUG

polyethylene glycol based bowel preparation

PEG-ELS

BLI800 DRUG

BLI800 bowel preparation

BLI800 high dose; BLI800 low dose

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female between the ages of 12 to 16 (inclusive)
• Undergoing colonoscopy for routinely accepted indications, including (but not limited to):
• Subjected inflammatory bowel disease (IBD) or IBD follow-up
• Lower gastrointestinal bleeding
• Suspected colitis (allergic or other)
• Abdominal pain
• Chronic diarrhea
• Cancer surveillance
• Anemia of unknown etiology
• Abnormal endosonography or manometry
• Evaluation of barium enema results
• If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
• Negative pregnancy test at screening, if applicable
• In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

You may not qualify if:

• Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
• Subjects who had previous significant gastrointestinal surgeries.
• Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
• Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, uncorrected dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
• Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
• Subjects with a prior history of renal, liver or cardiac insufficiency (including congestive heart failure or other significant cardiac abnormality)
• Subjects with estimated glomerular filtration rate (GFR) below normal range (less than 70 ml/min/1.73m2)
• Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
• Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
• Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
• Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
• Subjects undergoing colonoscopy for foreign body removal and/or decompression.
• Subjects with an abnormal ECG result at Visit 1.
• 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 (27)

Braintree Research Site 27

Mobile, Alabama, 36582, United States

Location

Braintree Research Site 30

Tucson, Arizona, 85724, United States

Location

Braintree Research Site 23

Orange, California, 92868, United States

Location

Braintree Research Site 16

San Francisco, California, 94158, United States

Location

Braintree Research Site 5

Gainesville, Florida, 32610, United States

Location

Braintree Research Site 24

Jacksonville, Florida, 32207, United States

Location

Braintree Research Site 21

Orlando, Florida, 32806, United States

Location

Braintree Research Site 2

Atlanta, Georgia, 30342, United States

Location

Braintree Research Site 13

Chicago, Illinois, 60611, United States

Location

Braintree Research Site 3

Park Ridge, Illinois, 60068, United States

Location

Braintree Research Site 26

Indianapolis, Indiana, 46202, United States

Location

Braintree Research Site 25

Minneapolis, Minnesota, 55454, United States

Location

Braintree Research Site 18

Rochester, Minnesota, 55905, United States

Location

Braintree Research Site 1

Flowood, Mississippi, 39232, United States

Location

Braintree Research Site 9

Buffalo, New York, 14222, United States

Location

Braintree Research Site 28

New York, New York, 10021, United States

Location

Braintree Research Site 19

New York, New York, 10032, United States

Location

Braintree Research Site 32

The Bronx, New York, 10467, United States

Location

Braintree Research Site 6

Pittsburgh, Pennsylvania, 15224, United States

Location

Braintree Research Site 20

Memphis, Tennessee, 38103, United States

Location

Braintree Research Site 34

Plano, Texas, 75093, United States

Location

Braintree Research Site 22

Salt Lake City, Utah, 84118, United States

Location

Braintree Research Site 10

Burlington, Vermont, 05401, United States

Location

Braintree Research Site 17

Norfolk, Virginia, 23507, United States

Location

Braintree Research Site 4

Roanoke, Virginia, 24013, United States

Location

Braintree Research Site 11

Seattle, Washington, 98105, United States

Location

Braintree Research Site 14

Milwaukee, Wisconsin, 53226, 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

  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: June 28, 2016
• First Posted: June 30, 2016
• Study Start: June 1, 2016
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: May 3, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)