NCT03017235

A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy

A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 917 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.

Conditions

• Bowel Preparation

Interventions

Type	Name	Description
DRUG	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution	Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.
DRUG	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder	Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-09-15
• Completion: 2017-10-12
• First posted: 2017-01-11
• Last updated: 2018-11-14
• Results posted: 2018-11-14

Locations

14 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study