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Same-day bowel preparation with 100 g Mannitol versus Plenvu (CLEARWAY)

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

PHASE3 · NTC srl · NCT07465705

This trial tests whether a single-dose 100 g Mannitol bowel prep works as well as the standard same-day Plenvu regimen for adults having elective colonoscopy.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment412 (estimated)
Ages18 Years and up
SexAll
SponsorNTC srl (industry)
Locations18 sites (Anderlecht and 17 other locations)
Trial IDNCT07465705 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized non-inferiority trial compares a 100 g Mannitol same-day regimen to the standard Plenvu (PEG-Asc) same-day regimen in adults scheduled for elective colonoscopy. Approximately half of participants receive Mannitol and half receive Plenvu, with bowel cleansing quality and safety recorded before the procedure. Enrollment follows ESGE guidelines for colonoscopy preparation and requires informed consent and ability to complete study procedures. Key safety exclusions include pregnancy, breastfeeding, and severe active inflammatory bowel disease.

Who should consider this trial

Good fit: Adults aged 18 years or older who can give informed consent and are scheduled for an elective colonoscopy are the intended participants.

Not a fit: People who are pregnant or breastfeeding, have severe active inflammatory bowel disease, or cannot tolerate oral bowel preparations are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, Mannitol could provide a safe, effective, and potentially lower-cost same-day bowel preparation alternative for patients undergoing elective colonoscopy.

How similar studies have performed: Mannitol has historical use and smaller studies have shown it can be effective for bowel cleansing, but high-quality Phase 3 comparisons against modern preparations like Plenvu are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

Exclusion Criteria:

1. 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).
2. 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.
3. Severe renal failure: eGFR \< 30 ml/min/1.73 m2 estimated by simplified MDRD equation.
4. Severe heart failure: New York Heart Association (NYHA) Class III-IV.
5. Severe anaemia (Hb ≤ 8 g/dl).
6. Chronic liver disease Child-Pugh class B or C.
7. Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges).
8. Clinically significant alterations of baseline haemato-chemical parameters.
9. Recent (\< 6 months) symptomatic acute ischemic heart disease.
10. 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.
11. History of paralysis of the gut (ileus).
12. History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
13. History of phenylketonuria (due to presence of aspartame).
14. History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
15. History of toxic megacolon.
16. 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.
17. Suspected bowel obstruction or perforation.
18. Indication for partial colonoscopy.
19. Subjects who received an investigational drug or therapy within 5 half-lives of the first visit.
20. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
21. Underwater colonoscopy instead of standard gas insufflation.

Where this trial is running

Anderlecht and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Elective Colonoscopy, Colonoscopy preparation, Bowel cleansing, Mannitol

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.