NCT03404401

A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy

BLI4700-301: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 620 (actual)
• Sponsor: Braintree Laboratories · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DRUG	BLI4700	Oral bowel preparation
DRUG	Polyethylene glycol bowel preparation	Oral bowel preparation

Timeline

• Start date: 2018-01-11
• Primary completion: 2018-07-10
• Completion: 2018-07-10
• First posted: 2018-01-19
• Last updated: 2021-09-08
• Results posted: 2021-09-08

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study