CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 91 enrolled
Drug / intervention
PEG-ELS +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 12 to 16 years (inclusive)
  • ✓Undergoing colonoscopy for routinely accepted indications such as IBD, lower GI bleeding, colitis, abdominal pain, chronic diarrhea, cancer surveillance, anemia, abnormal endosonography/manometry, or barium enema evaluation
  • ✓If female and of childbearing potential, must use acceptable birth control or remain abstinent for study duration
  • ✓Caregiver mentally competent to provide informed consent
Key exclusion· 12
  • ✕Known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, GI obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon
  • ✕Prior significant gastrointestinal surgery
  • ✕Increased risk of bowel perforation including connective tissue disorders, toxic dilation, or recent bowel surgery
  • ✕Uncontrolled or clinically significant electrolyte abnormalities (hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia) or uncorrected dehydration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02819323
NCT02819323Phase 3Completed
CompareCT.gov

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

Braintree Laboratories·interventional·Posted Jun 30, 2016·Updated May 3, 2021

In Brief

A Phase 3 clinical trial evaluating PEG-ELS and BLI800 for Colonoscopy. Completed, enrolled 91 participants across 27 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonoscopy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 30, 2016
Enrollment StartJun 1, 2016
Primary CompletionMar 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.0 years ago

Interventions

PEG-ELSdrug

polyethylene glycol based bowel preparation

BLI800drug

BLI800 bowel preparation