NCT01928862

Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy

A Randomized, Assessor-Blind, Multicenter, Dose-Ranging Study Comparing the Safety and Efficacy of Prepopik® Versus Polyethylene Glycol Preparation (Local Standard of Care) in Children Aged 9 Years to 16 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 9 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy

Conditions

• Need for Bowel Preparation

Interventions

Type	Name	Description
DRUG	Prepopik® ½ Sachet x 2 (9-12 years)
DRUG	Prepopik® 1 Sachet x 2 (9-12 years)
DRUG	Oral polyethylene glycol (PEG) based preparation (9-12 years)
DRUG	Prepopik® 1 Sachet x 2 (13-16 years)
DRUG	Oral polyethylene glycol (PEG) based preparation (13-16 years)

Timeline

• Start date: 2014-06-03
• Primary completion: 2017-02-15
• Completion: 2017-03-16
• First posted: 2013-08-27
• Last updated: 2018-04-23
• Results posted: 2018-04-23

Locations

9 sites across 1 country: United States