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RECRUITING
NCT07465705
PHASE3

Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)

Sponsor: NTC srl

View on ClinicalTrials.gov

Summary

This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.

Official title: A Phase III, International, Multicenter, Randomized, Parallel-group, Endoscopist-blinded Non-inferiority Study of the Efficacy, Safety and Patient Acceptance of Mannitol Versus Plenvu® in Bowel Preparation for Elective Colonoscopy. CLEARWAY

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

412

Start Date

2025-09-02

Completion Date

2026-06-30

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

100g of Mannitol

Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water

DRUG

1L PEG-Asc

Self administration of the same day preparation according to the on lable instruction for use. The first dose consists in dissolving Dose 1 in 500ml of water, followed by another 500ml of water, all within 1 hour. After a 1 hour wait from the end of the first dose, the participant should self administer the Dose 2 consisting in dissolving one sachetA and one sachetB in 500ml of water, followed by another 500ml of water; all within 1 hour.

Locations (18)

Hopital Erasme

Anderlecht, Belgium

Katholieke Universiteit te Leuven

Leuven, Belgium

Algemeen Ziekenhuis Damiaan Oostende

Ostend, Belgium

Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi

Carpi, Modena, Italy

Centro Di Riferimento Oncologico Di Aviano

Aviano, Pordenone, Italy

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Verona, Italy

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Bologna, Italy

Fondazione Poliambulanza

Brescia, Italy

Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce

Como, Italy

Fondazione IRCCS Cà Granda Ospedale Policlinico

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Policlinico Universitario A. Gemelli

Roma, Italy

Azienda Provinciale Per I Servizi Sanitari

Trento, Italy

H-T.Centrum Medyczne Sp. z o.o. sp.k.

Tychy, Poland

Klinika Reuma Park Sp. z o.o. S.K.

Warsaw, Poland

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Hospital Clinic De Barcelona

Barcelona, Spain

Region Oerebro Laen

Örebro, Sweden