CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 917 enrolled
Drug / intervention
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution +1 moredrug
Likely dose
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution 160 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03017235
NCT03017235Phase 3Completed

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

Ferring Pharmaceuticals·interventional·Posted Jan 11, 2017·Updated Nov 14, 2018

In Brief

A Phase 3 clinical trial evaluating Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution and Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder for Bowel Preparation. Completed, enrolled 917 participants across 14 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 11, 2017
Enrollment StartFeb 20, 2017
Primary CompletionSep 15, 2017
Study CompletionOct 12, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.5 years ago

Interventions

Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solutiondrug

Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.

Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powderdrug

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.