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

Recruiting now · Phase 3

Conditions studied: Elective Colonoscopy

In brief

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®.

Key facts

Study ID

NCT07465705

Run by

NTC srl

People needed

412

Starts

2025-09-02

Expected to finish

2026-06-30

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability of subject to consent and provide signed written informed consent.
• Age ≥ 18 years.
• Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
• Subjects willing and able to complete the entire study and to comply with instructions.

You may not qualify if…

• Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG "Recommendations related to contraception and pregnancy testing in clinical trials" v 1.2* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy).
• Severe acute and chronically active inflammatory bowel disease; subjects in clinical remission (Crohn's Disease Activity Index - CDAI < 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are allowed.
• Severe renal failure: eGFR < 30 ml/min/1.73 m2 estimated by simplified MDRD equation.
• Severe heart failure: New York Heart Association (NYHA) Class III-IV.
• Severe anaemia (Hb ≤ 8 g/dl).
• Chronic liver disease Child-Pugh class B or C.
• Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges).
• Clinically significant alterations of baseline haemato-chemical parameters.
• Recent (< 6 months) symptomatic acute ischemic heart disease.
• History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann's procedure and other surgeries involving the structure and function of the colon.
• History of paralysis of the gut (ileus).
• History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
• History of phenylketonuria (due to presence of aspartame).
• History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
• History of toxic megacolon.
• Use within 24 hours prior to colonoscopy of laxatives, colon motility altering drugs and/or other substances (e.g., simethicone) that could affect bowel cleansing or visibility during colonoscopy.
• Suspected bowel obstruction or perforation.
• Indication for partial colonoscopy.
• Subjects who received an investigational drug or therapy within 5 half-lives of the first visit.
• Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
• Underwater colonoscopy instead of standard gas insufflation.

Where it is running

• Region Oerebro Laen — Örebro, Sweden (enrolling)
• Katholieke Universiteit te Leuven — Leuven, Belgium (enrolling)
• Algemeen Ziekenhuis Damiaan Oostende — Ostend, Belgium (enrolling)
• Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi — Carpi, Modena, Italy (enrolling)
• Centro Di Riferimento Oncologico Di Aviano — Aviano, Pordenone, Italy (enrolling)
• IRCCS Ospedale Sacro Cuore Don Calabria — Negrar, Verona, Italy (enrolling)
• Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico — Bologna, Italy (enrolling)
• Fondazione Poliambulanza — Brescia, Italy (enrolling)
• Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce — Como, Italy (enrolling)
• Fondazione IRCCS Cà Granda Ospedale Policlinico — Milan, Italy (enrolling)
• Istituto Europeo di Oncologia — Milan, Italy (enrolling)
• Policlinico Universitario A. Gemelli — Roma, Italy (enrolling)
• Azienda Provinciale Per I Servizi Sanitari — Trento, Italy (enrolling)
• H-T.Centrum Medyczne Sp. z o.o. sp.k. — Tychy, Poland (enrolling)
• Hopital Erasme — Anderlecht, Belgium (enrolling)
• Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy — Warsaw, Poland (enrolling)
• Hospital Clinic De Barcelona — Barcelona, Spain (enrolling)
• Klinika Reuma Park Sp. z o.o. S.K. — Warsaw, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.