Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy

Summary

The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight \>40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.

Timeline

Start

2017-10-15

Primary completion

2020-02-24

Completion

2020-06-29

Outcome

Missed primary endpoint

registry analysis (non-inferiority test); Eziclen®/Izinova® vs Klean-Prep®; p = 0.0907; Adjusted treatment difference -7.61 (95% CI -18.45 to 3.24) NCT03008460 ↗

paper CONCLUSIONS: Non-inferiority of OSS to PEG was not demonstrated PMID 36821851 ↗

Publications

• Socha P, Posovszky C, Szychta M, Viscogliosi F, Martemucci L, Grzybowska-Chlebowczyk U, Perrot V, Kornowski A, Benninga MA; EASYKID Study Group. Phase III Randomized Non-Inferiority Study of OSS Versus PEG + Electrolyte Colonoscopy Preparation in Adolescents. J Pediatr Gastroenterol Nutr. 2023 May 1;76(5):652-659. doi: 10.1097/MPG.0000000000003745. Epub 2023 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eziclen	Other / unclassified	—	Oral
Comparator	Klean-Prep®	Other / unclassified	—	Oral

Indications