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Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®

NCT04759885 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 886

Last updated 2025-12-08

Study results available
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Summary

The purpose of this dose finding/comparative efficacy study is to first single out the most appropriate dose of mannitol for bowel preparation (phase II) and, subsequently, demonstrate the non-inferiority of the efficacy of single dose mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .

Conditions

  • Elective Colonoscopy

Interventions

DRUG

Phase II: NTC015 low dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

DRUG

Phase II: NTC015 medium dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

DRUG

Phase II: NTC015 high dose

Participants should self administer the preparation within 60 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

DRUG

Phase III: NTC015 selected dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

DRUG

Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC)

The instructions for product administration are followed according to the Summary of Product Characteristics. One treatment consists of two litres of Moviprep® taken according to split-dose regimen. The first litre of Moviprep® is prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution. The reconstituted solution must be drunk over a period of one to two hours the evening before colonoscopy. About half a litre of clear liquid should be drunk in the next hour to prevent dehydration according to local practice at the centre. This process should be repeated with a second litre of Moviprep® prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution in the early morning of the day of the procedure.

Sponsors & Collaborators

  • NTC srl

    lead INDUSTRY

Principal Investigators

  • Gianpiero Manes, Dr. · ASST Rhodense - Presidi di Rho e Garbagnate

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2021-07-16
Completion
2021-07-16

Countries

  • France
  • Germany
  • Italy
  • Russia

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 NCT04759885 on ClinicalTrials.gov