CC BY-NC-ND 4.0 · Endosc Int Open 2018; 06(08): E907-E913
DOI: 10.1055/a-0624-2266
Original article
Owner and Copyright © Georg Thieme Verlag KG 2018

Efficacy and safety of a new low-volume PEG with citrate and simethicone bowel preparation for colonoscopy (Clensia): a multicenter randomized observer-blind clinical trial vs. a low-volume PEG with ascorbic acid (PEG-ASC)

Patrizia Kump
1  Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University Graz, Graz, Austria
,
Cesare Hassan
2  Gastroenterology Department, Nuovo Regina Margherita Hospital, Rome, Italy
,
Cristiano Spada
3  Digestive Endoscopy Unit, Catholic University, Rome, Italy
4  Digestive Endoscopy Unit, Fondazione Poliambulanza, Brescia, Italy
,
Eva Brownstone
5  Internal Medicine IV, KH Rudolfstiftung, Vienna, Austria
,
Christian Datz
6  Department of Internal Medicine, Oberndorf Hospital, Teaching Hospital of the Paracelsus Medical University, Salzburg, Austria
,
Michael Haefner
7  Department of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
,
Friedrich Renner
8  Interne Abteilung, Krankenhaus der Barmherzigen Schwestern Ried, Ried, Austria
,
Rainer Schoefl
9  Internal Medicine IV, KH der Elisabethinen, Linz, Austria.
,
Florian Schreiber
1  Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University Graz, Graz, Austria
› Author Affiliations
TRIAL REGISTRATION: Multi-centre, Randomised, Observer-blind, Comparative Trial EU-CTR 2010-019317-22 at clinicaltrialsregister.eu
Further Information

Publication History

submitted 20 November 2017

accepted after revision 05 March 2018

Publication Date:
01 August 2018 (online)

  

Abstract

Background and study aims Quality of inspection during colonoscopy is strictly related to the level of cleansing. High-volume (PEG-based) solutions are highly effective and safe, but their high volume affects tolerability and compliance. The aim of this study was to compare a new low-volume PEG with citrate and simethicone solution (PMF 104,Clensia) with a low-volume PEG with ascorbic acid solution (PEG-ASC; Moviprep).

Patients and methods This was a multicenter, randomized, observer-blind, parallel-group, phase 3 clinical trial, where patients were randomized between PMF 104 and PEG-ASC. In both groups, patients were instructed to take a full-dose regimen the evening before if colonoscopy was scheduled before 11 am to 12 pm, or to take a split regimen if colonoscopy was scheduled after 11 am to 12 pm. The primary end-point was an equivalence between PMF104 and PEG-ASC in the rate of adequate level of cleansing (Ottawa scale ≤ 6), with safety, mucosal visibility, tolerability, acceptance and compliance being also assessed.

Results Of the 403 enrolled, 367 patients (Mean age [SD]: 55.6 (14.4) years; male:166 [45.2 %]) were included in the per protocol (PP) analysis: 184 being randomized in the PMF 104 group and 183 in the PEG-ASC group. Successful bowel cleansing was 78.3 % and 74.3 % in PMF104 and in PEG-ASC, respectively (P = 0.37). Both preparations were equally safe (mild adverse events were observed in 9.2 % and 9.3 % of patients in the PMF104 and in the PEG-ASC group, respectively) and acceptable (no or mild distress during the intake in 81.4 % and 80.8 % in the PMF104 in the PEG-ASC, respectively [P = 0.74]).

Conclusion The new low-volume product Clensia is equivalent to the reference low-volume PEG-ASC in terms of bowel cleansing, safety and acceptance.