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

NCT07465705 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-03-13

No results posted yet for this 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®.

Conditions

  • Elective Colonoscopy

Interventions

DRUG

100g of Mannitol

Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water

DRUG

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.

Sponsors & Collaborators

  • NTC srl

    lead INDUSTRY

Principal Investigators

  • Cristiano Spada, Prof. · Policlinico Universitario A. Gemelli

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Belgium
  • Italy
  • Poland
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07465705 on ClinicalTrials.gov