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

Completed · Phase 3

Conditions studied: Colonoscopy

In brief

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.

Key facts

Study ID

NCT02819323

Run by

Braintree Laboratories

People needed

91

Starts

2016-06-01

Expected to finish

2018-03-27

Last updated by the study team

2021-05-03

Who can join

Age: 12 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

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.
• Subjects with a history of hypersensitivity to any preparation components.
• Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures and history of major medical/psychiatric conditions that would compromise the safety of the study.
• Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
• Subjects who withdraw consent before completion of Visit 1 procedures.

Where it is running

• Braintree Research Site 27 — Mobile, Alabama, United States
• Braintree Research Site 30 — Tucson, Arizona, United States
• Braintree Research Site 23 — Orange, California, United States
• Braintree Research Site 16 — San Francisco, California, United States
• Braintree Research Site 5 — Gainesville, Florida, United States
• Braintree Research Site 24 — Jacksonville, Florida, United States
• Braintree Research Site 21 — Orlando, Florida, United States
• Braintree Research Site 2 — Atlanta, Georgia, United States
• Braintree Research Site 13 — Chicago, Illinois, United States
• Braintree Research Site 3 — Park Ridge, Illinois, United States
• Braintree Research Site 26 — Indianapolis, Indiana, United States
• Braintree Research Site 25 — Minneapolis, Minnesota, United States
• Braintree Research Site 18 — Rochester, Minnesota, United States
• Braintree Research Site 1 — Flowood, Mississippi, United States
• Braintree Research Site 9 — Buffalo, New York, United States
• Braintree Research Site 28 — New York, New York, United States
• Braintree Research Site 19 — New York, New York, United States
• Braintree Research Site 32 — The Bronx, New York, United States
• Braintree Research Site 6 — Pittsburgh, Pennsylvania, United States
• Braintree Research Site 20 — Memphis, Tennessee, United States
• Braintree Research Site 34 — Plano, Texas, United States
• Braintree Research Site 22 — Salt Lake City, Utah, United States
• Braintree Research Site 10 — Burlington, Vermont, United States
• Braintree Research Site 17 — Norfolk, Virginia, United States
• Braintree Research Site 4 — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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