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

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Last updated:1st Oct 2014

This study evaluates the efficacy, safety and tolerability of NER1006 compared with MOVIPREP in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day Split-Dosing and 1-Day Morning 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.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: 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 a 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimens in Adults.
Enrollment: 849
Study Start Date: October 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
NER1006, 2-Day Split-Dosing
- Experimental: NER1006,1-Day Morning Split-Dosing
- Active Comparator: MOVIPREP, 2-Day Split-Dosing

Category Value
Study start date 2014-10-01

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