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Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)
Sponsor: NTC srl
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
Conditions
Interventions
100g of Mannitol
Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water
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