Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen … (NCT07465705) | Clinical Trial Compass
RecruitingPhase 3
Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)
Belgium, Italy412 participantsStarted 2025-09-02
Plain-language 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®.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score
Timeframe: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)