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

Registry ID
EUCTR2019-003749-14
Source registry
EUCTR
Phase
PHASE2
Sponsor
Braintree Laboratories
Last update
2026-08-16

Conditions

Summary

The objective of this study is to compare the safety, tolerability and efficacy of the FDA approved split-dose adult regimen of BLI800 (i.e., two 6 ounce bottles of oral solution, each bottle containing: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams) to a reduced 3/4 volume of BLI800 (4.5 ounces per dose), as bowel preparations prior to colonoscopy in pediatric patients ages 12 to 17 years.

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