Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy

Summary

A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)

Timeline

Start

2012-10

Primary completion

2013-07

Completion

2014-01

Outcome

Met primary endpoint

paper LVPEG-3 achieved the largest mean stool weight (3399 g: P < 0.0001 vs target) PMID 31146679 ↗

paper LVPEG-4 (3215 g: P < 0.001), which achieved 100% cleansing success PMID 31146679 ↗

Publications

• Clayton LB, Tayo B, Halphen M, Kornberger R. Novel 1 L polyethylene glycol-based bowel preparation (NER1006): proof of concept assessment versus standard 2 L polyethylene glycol with ascorbate - a randomized, parallel group, phase 2, colonoscopist-blinded trial. BMC Gastroenterol. 2019 May 30;19(1):79. doi: 10.1186/s12876-019-0988-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Moviprep	Other / unclassified	2000 ml	—
Subject	Polyethylene Glycol 3350	Other / unclassified	1000 ml	—
Subject	Polyethylene Glycol 3350	Other / unclassified	1250 ml	—

Indications