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.

PHASE3CompletedINTERVENTIONAL
Enrollment

849

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Colorectal CancerColorectal CarcinomaColon Cleansing
Interventions
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.

Trial Locations (29)

Unknown

AZ Sint-Lucas, Bruges

UZ Ghent, Ghent

CHC- Clinique Saint-Joseph, Liège

Hôpital Avicenne- Service de Gastro-Entérologie, Bobigny

Hôpital Hotel-Dieu, Nantes

Kliniken Essen-Mitte; Abteilung für Gastroenterologie, Essen

Klinikum der Friedrich Schiller Universität Jena, Jena

Praxis für Innere Medizin, Gastroenterologie und Allg. Medizin, Ludwigshafen

A.O.U. di Bologna - Policlinico S. Orsola-Malpighi, Bologna

Ospedale Valduce U.O. Gastroenterologia e Endoscopia, Como

P.O. Maresca OORR Area Vesuviana ASL, Naples

Centro di Riferimento Oncologico (C.R.O.) S.O.C Gastroenterologia, Pordenone

Pol. Univ. A. Gemelli U.O. di Endoscopia Digestiva Chirurgica, Roma

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

Gabinet Internistyczny dr n. med. Krzysztof Janik, Częstochowa

NZOZ Centrum Medyczne-Szpital Swietej Rodziny, Lodz

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych, Warsaw

Robert Petryka Gabinet Internistyczny, Warsaw

Lexmedica Durbajlo Hanna, Wroclaw

Hospital General Universitario de Alicante, Alicante

Hospital del Mar, Barcelona

Hospital Universitari Germans Trias i Pujol, Barcelona

Hospital Clínico San Carlos, Madrid

Hospital Ramon y Cajal - Ctra. De Colmenar km. 9, 100, Madrid

Lothian Health Board, Edinburgh

Borders General Hospital, Melrose

Royal Shrewsbury Hospital, Shrewsbury

Royal Albert Edward Infirmary Department, Wigan

3000 Leuven

UZ Leuven, Leuven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Norgine

INDUSTRY