Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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®.
Eligibility
Primary outcome measure(s)
- Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score — During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 after standard washing and air or CO2 insufflation for luminal distension.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Hopital Erasme | Anderlecht | Belgium | Recruiting |
| Katholieke Universiteit te Leuven | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Damiaan Oostende | Ostend | Belgium | Recruiting |
| Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi | Carpi | Modena | Recruiting |
| Centro Di Riferimento Oncologico Di Aviano | Aviano | Pordenone | Recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | Verona | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Recruiting |
| Fondazione Poliambulanza | Brescia | Italy | Recruiting |
| Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce | Como | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Policlinico | Milan | Italy | Recruiting |
| Istituto Europeo di Oncologia | Milan | Italy | Recruiting |
| Policlinico Universitario A. Gemelli | Roma | Italy | Recruiting |
| Azienda Provinciale Per I Servizi Sanitari | Trento | Italy | Recruiting |
| H-T.Centrum Medyczne Sp. z o.o. sp.k. | Tychy | Poland | Recruiting |
| Klinika Reuma Park Sp. z o.o. S.K. | Warsaw | Poland | Active Not Recruiting |
| Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Warsaw | Poland | Recruiting |
| Hospital Clinic De Barcelona | Barcelona | Spain | Recruiting |
| Region Oerebro Laen | Örebro | Sweden | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07465705 on ClinicalTrials.gov ↗ ← All trials in Spain