Clinical trial NCT02189850: Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonoscopy
Keywords: colonoscopy
pediatric
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2014-07-15
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a bowel preparation prior to colonoscopy in pediatric patients.


Eligibility criteria: Key Inclusion Criteria:

* Male or female between the ages of 12 to 17
* Weight more than 40kg
* Undergoing colonoscopy for routinely accepted indications
* 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 Criteria:

* 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
* Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
* Subjects with a prior history of renal, liver or cardiac insufficiency
* 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.

Primary outcomes:
measure: % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care
state: Georgia
city: Bastrop
country: United States
facility: Delta Research Partners
state: Louisiana
city: Jackson
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Buffalo
country: United States
facility: University of Buffalo Pediatric Associates
state: New York
Study officials:
References: