NCT02273167

Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.

A Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 (a Low Volume Bowel Cleansing Solution) Versus MOVIPREP Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 849 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens. Approximately 810 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 3 groups.

Conditions

• Colorectal Cancer
• Colorectal Carcinoma
• Colon Cleansing

Interventions

Type	Name	Description
DRUG	NER1006, 2-Day Split-Dosing	The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
DRUG	NER1006,1-Day Morning Split-Dosing	The subject will self-administer the first dose of the investigational product on the morning of the colonoscopy and take mandatory additional clear fluid. After a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid.
DRUG	MOVIPREP, 2-Day Split-Dosing	The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take recommended additional clear fluid. Subject will take the second dose together with recommended additional clear fluids on the morning of the colonoscopy.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-10-23
• Last updated: 2018-05-15
• Results posted: 2017-04-18

Locations

29 sites across 7 countries: Belgium, France, Germany, Italy, Poland, Spain, United Kingdom