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.

ABSTRACT: BACKGROUND:Colonoscopy requires colon cleansing. For this, many polyethylene glycol (PEG)-based preparations still require a high preparation-volume intake. Using an increased osmotic load with ascorbate (Asc), five new low-volume PEG-based bowel preparations (LVPEG) were tested for clinical proof of concept. METHODS:This two-part, open-label study examined preparation-volumes of 1-1.25?L and total required fluid volumes of 2-3?L. Part 1, in healthy volunteers, used mean cumulative 24-h stool weight (target >?2750?g) to identify a lead candidate. Part 2 was endoscopist-blinded: patients undergoing screening colonoscopy were randomized before treatment with the selected lead, one of two variants of it, or the control 2?L PEG + Asc. Two primary endpoints were used for proof of concept demonstration: mean 24-h stool weight and bowel cleansing success (Harefield Cleansing Scale). RESULTS:A total of 120 subjects (30 per group) were enrolled/randomized 1:1:1:1 (max 40:60 gender ratio) per completed Part. In Part 1, LVPEG-3 achieved the largest mean stool weight (3399?g: P?

SUBMITTER: Clayton LB 

PROVIDER: S-EPMC6543558 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature