Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

886

Participants

Timeline

Start Date

June 18, 2020

Primary Completion Date

July 16, 2021

Study Completion Date

July 16, 2021

Conditions
Elective Colonoscopy
Interventions
DRUG

Phase II: NTC015 low dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

DRUG

Phase II: NTC015 medium dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

DRUG

Phase II: NTC015 high dose

Participants should self administer the preparation within 60 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

DRUG

Phase III: NTC015 selected dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

DRUG

Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC)

"The instructions for product administration are followed according to the Summary of Product Characteristics.~One treatment consists of two litres of Moviprep® taken according to split-dose regimen.~The first litre of Moviprep® is prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution. The reconstituted solution must be drunk over a period of one to two hours the evening before colonoscopy. About half a litre of clear liquid should be drunk in the next hour to prevent dehydration according to local practice at the centre. This process should be repeated with a second litre of Moviprep® prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution in the early morning of the day of the procedure."

Trial Locations (35)

20024

ASST Rhodense - Presidi di Rho e Garbagnate, Garbagnate Milanese

20097

IRCCS Policlinico San Donato, San Donato Milanese

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21100

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi, Varese

25124

Fondazione Poliambulanza - Istituto Ospedaliero, Brescia

28100

Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara

33081

Centro di Riferimento Oncologico IRCCS, Aviano

37024

Ospedale Sacro Cuore, Negrar

38100

Presidio Ospedaliero Santa Chiara, Trento

41012

Azienda USL di Modena - Ospedale Ramazzini di Carpi, Carpi

56124

Azienda Ospedaliero Universitaria Pisana- Ospedale Cisanello, Pisa

70013

"IRCCS Saverio De Bellis", Castellana Grotte

71013

Fondazione Casa Sollievo Della Sofferenza, San Giovanni Rotondo

Unknown

Centre Hospitalier Henri Duffaut, Avignon

Hospices civils de Lyon, Lyon

Hôpital Edouard Herriot, Lyon

Centre Hospitalier Universitaire de Montpellier, Montpellier

Klinikum der Stadt Ludwigshafen, Ludwigshafen

Praxis für Gastroenterologie und Fachärztliche Innere Medizin, Im Haus der Gesundheit, Ludwigshafen am Rhein

Katholisches Klinikum Mainz, Mainz

Klinikum Worms Medizinische Klinik II, Worms

ASSL Carbonia - Presidio Ospedaliero CTO di Iglesias, Iglesias

Ospedale Valduce, Como

IRCCS Ospedale San Raffaele, Milan

Istituto Europeo di Oncologia, Milan

Irkutsk State Medical Academy of Postgraduate Education, Irkutsk

Clinical Hospital of Russian Railways N.A. Semashko, Moscow

Moscow Clinical Research and Practical Center of the Department of Health, Moscow

State Central Clinical Hospital A. N. Ryzhykh, Moscow

Railway Clinical Hospital, Rostov

"Private educational organization of higher education Medical University Reaviz", Samara

Medical Center of Diagnostics and Prevention, Yaroslavl

Regional Oncological Clinical Hospital, Yaroslavl

00168

Policlinico Universitario A. Gemelli, Roma

All Listed Sponsors
lead

NTC srl

INDUSTRY

NCT04759885 - Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep® | Biotech Hunter | Biotech Hunter