Status:
COMPLETED
A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Lead Sponsor:
Braintree Laboratories
Conditions:
Colonoscopy
Eligibility:
All Genders
12-16 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2018
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT02819323
Start Date
June 1 2016
End Date
March 27 2018
Last Update
May 3 2021
Active Locations (27)
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1
Braintree Research Site 27
Mobile, Alabama, United States, 36582
2
Braintree Research Site 30
Tucson, Arizona, United States, 85724
3
Braintree Research Site 23
Orange, California, United States, 92868
4
Braintree Research Site 16
San Francisco, California, United States, 94158