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

Study Overview
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Brief Summary
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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.

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: BLI800 - Dose 1
* Drug: BLI800 - Dose 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI800 - Dose 1<br>BLI800 oral solution | Drug: BLI800 - Dose 1<br>* BLI800 oral solution<br>* Other names: BLI800;|
| Experimental: BLI800 - Dose 2<br>BLI800 oral solution | Drug: BLI800 - Dose 2<br>* BLI800 oral solution<br>* Other names: BLI800;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent) | Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist. Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, pediatric