Endoscopy 2019; 51(01): 73-84
DOI: 10.1055/a-0639-5070
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial

Stefan Schreiber
1  University Hospital Schleswig-Holstein, Kiel, Germany
,
Daniel C. Baumgart
2  Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada
,
Joost P. H. Drenth
3  Radboud University Medical Centre, Nijmegen, The Netherlands
,
Rafał S. Filip
4  University of Rzeszów, Rzeszów, Poland
5  Institute of Rural Health, Lublin, Poland
,
Lucy B. Clayton
6  Clinical Development, Norgine Ltd, Harefield, United Kingdom
,
Kerry Hylands
6  Clinical Development, Norgine Ltd, Harefield, United Kingdom
,
Alessandro Repici
7  Department of Gastroenterology, Humanitas Research Hospital, Milan, Italy
8  Department of Medical Bioscience, Humanitas University, Milan, Italy
,
Cesare Hassan
9  Ospedale Nuovo Regina Margherita, Rome, Italy
,
on behalf of the DAYB Study Group› Author Affiliations
TRIAL REGISTRATION: Multicenter, randomized, parallel group, phase 3 study 02273141 at clinicaltrials.gov
Further Information

Publication History

submitted 22 December 2017

accepted after revision 11 May 2018

Publication Date:
19 July 2018 (eFirst)

Abstract

Background Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing.

Methods Patients requiring colonoscopy were randomized (1 : 1) to receive NER1006 or SP + MC. Cleansing was assessed on the Harefield Cleansing Scale (HCS) and Boston Bowel Preparation Scale (BBPS) using central readers. Two primary end points were assessed: overall colon cleansing success and high-quality cleansing of the right colon. Intention-to-treat (modified full analysis set [mFAS]) and per protocol (PP) analyses were performed.

Results Of 515 patients, efficacy was analyzed in 501 (NER1006, n = 250; SP + MC, n = 251) and 379 patients (NER1006, n = 172; SP + MC, n = 207) in the mFAS and PP analyses, respectively. Non-inferiority of NER1006 vs. SP + MC was established in the mFAS for both overall cleansing (62.0 % vs. 53.8 %; P = 0.04) and high-quality cleansing in the right colon (4.4 % vs. 1.2 %; P = 0.03). Superiority of NER1006 was demonstrated using HCS in the PP set for overall cleansing success (68.0 % vs. 57.5 %; P = 0.02) and right colon high-quality cleansing (5.2 % vs. 1.0 %; P = 0.02) and using BBPS in the mFAS for overall cleansing success (58.4 % vs. 45.8 %; P = 0.003) and right colon high-quality cleansing (4.0 % vs. 0.8 %; P = 0.02). Mean segmental scores for 4/5 segments were higher with NER1006 (P ≤ 0.04). Both treatments were well tolerated, with more mild adverse events for NER1006 (17.0 % vs. 10.0 %; P = 0.03).

Conclusions Colon cleansing with NER1006 vs. SP + MC was non-inferior (mFAS) and superior (PP), with acceptable safety.

European Clinical Trials Database (EudraCT)

2014-002186-30

TRIAL REGISTRATION: Multicenter, randomized, parallel group, phase 3 study 2014-002186-30 at https://eudract.ema.europa.eu/

Table e1 – e3, Table e5, Fig. e5, Fig. e6 and Fig. e9