MedTrace Logo

A Trial to Evaluate the Efficacy and Safety of PMF104 Compared to a Conventional PEG-electrolyte Solution in Children

NCT03106922 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2018-09-28

No results posted yet for this study

Summary

A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to a conventional PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning the colon.

Conditions

  • Bowel Preparation Before Colonoscopy

Interventions

DRUG

PMF104

Powder for oral solution: * Sachet A: macrogol 4000 52.500 g, anhydrous sodium sulphate 3.750 g, simeticone 0.080 g; * Sachet B: sodium citrate 1.863 g, anhydrous citric acid 0.813 g, sodium chloride 0.730 g, potassium chloride 0.370 g; One sachet A + 1 sachet B in 500 ml of water

DRUG

Klean-prep

Powder for oral solution: macrogol 3350 59.000 g, anhydrous sodium sulphate 5.685 g, sodium bicarbonate 1.685 g, sodium chloride 1.465 g, potassium chloride 0.7425 g. One sachet to be dissolved in 1 L of water

Sponsors & Collaborators

  • Alfasigma S.p.A.

    lead INDUSTRY

Principal Investigators

  • Salvatore Cucchiara, MD · Azienda Policlinico Umberto I

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Belgium
  • France
  • Italy

Study Locations

More Related Trials

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 NCT03106922 on ClinicalTrials.gov