Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)
Recruiting
Phase 3
Interventional Study
Elective Colonoscopy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 412 (estimated)
- Sponsor
- NTC srl · Industry
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About This Trial
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®.
Trial Locations
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Eligibility 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 instructi…
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