Spots Global Cancer Trial Database for 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.
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Trial Identification
Brief Title: 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.
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 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.
Study ID: NCT02273167
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
AZ Sint-Lucas, Brugge, , Belgium
UZ Ghent, Ghent, , Belgium
UZ Leuven, Leuven, , Belgium
CHC- Clinique Saint-Joseph, Liège, , Belgium
Hôpital Avicenne- Service de Gastro-Entérologie, Bobigny, , France
Hôpital Hotel-Dieu, Nantes, , France
Kliniken Essen-Mitte; Abteilung für Gastroenterologie, Essen, , Germany
Klinikum der Friedrich Schiller Universität Jena, Jena, , Germany
Praxis für Innere Medizin, Gastroenterologie und Allg. Medizin, Ludwigshafen, , Germany
A.O.U. di Bologna - Policlinico S. Orsola-Malpighi, Bologna, , Italy
Ospedale Valduce U.O. Gastroenterologia e Endoscopia, Como, , Italy
P.O. Maresca OORR Area Vesuviana ASL, Naples, , Italy
Centro di Riferimento Oncologico (C.R.O.) S.O.C Gastroenterologia, Pordenone, , Italy
Pol. Univ. A. Gemelli U.O. di Endoscopia Digestiva Chirurgica, Roma, , Italy
Uniwersytecki Szpital Kliniczny w Bialymstoku, Białystok, , Poland
Gabinet Internistyczny dr n. med. Krzysztof Janik, Czestochowa, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych, Warsaw, , Poland
Robert Petryka Gabinet Internistyczny, Warsaw, , Poland
Lexmedica Durbajlo Hanna, Wrocław, , Poland
NZOZ Centrum Medyczne-Szpital Swietej Rodziny, Łódź, , Poland
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Ramon y Cajal - Ctra. De Colmenar km. 9, 100, Madrid, , Spain
Lothian Health Board, Edinburgh, , United Kingdom
Borders General Hospital, Melrose, , United Kingdom
Royal Shrewsbury Hospital, Shrewsbury, , United Kingdom
Royal Albert Edward Infirmary Department, Wigan, , United Kingdom
Contact Details
Name: Raf Bisschops, MD
Affiliation: UZ Leuven
Role: PRINCIPAL_INVESTIGATOR
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