Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults.

PHASE3CompletedINTERVENTIONAL
Enrollment

515

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Colorectal CancerColorectal CarcinomaColon Cleansing
Interventions
DRUG

NER1006, Day Before-Only Dosing

The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose.

DRUG

SP+MS, Day Before-Only Dosing

The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.

Trial Locations (19)

24105

University Hospital Schleswig-Holstein, Kiel

Unknown

Charité - Campus Virchow Klinikum, Berlin

An der Germania Brauerei 6, Münster

An der Germania Brauerei 6, Milan

Osp.San Raffaele U.O. Gastroenterologia, Milan

P.T.P.Nuovo Regina Margherita, Rome

Onze Lieve Vrouwe Gashuis, Amsterdam

Albert Schweitzer Ziekenhuis, Dordrecht

Radboud UMC, Nijmegen

Orbis Medisch Centrum, Sittard

Centrum Medyczne sw. Lukasza, Częstochowa

Instytut Medycyny Wsi im. Witolda Chodzki w, Lubliniec

Specjalistyczna Praktyka Lekarska dr med. Marek Horynski, Sopot

SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego, Szczecin

Hospital de Vinalopó, Unidad de Endoscopia Digestiva, Elche

Hospital Universitario de la Princesa, Madrid

Hospital Universitario La Paz, Unidad Enfermedad Intestinal, Madrid

Department of Surgery, Raigmore Hospital, Inverness

Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Norgine

INDUSTRY