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

PHASE3UnknownINTERVENTIONAL
Enrollment

430

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

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"

Trial Locations (9)

1090

NOT_YET_RECRUITING

Pediatric Gastroenterology, Hepatology and Nutrition Children's University Hospital, Brussels

40133

ACTIVE_NOT_RECRUITING

"Ospedale Maggiore C.A. Pizzardi AUSL Bologna", Bologna

50139

ACTIVE_NOT_RECRUITING

Azienda Ospedaliero-Universitaria Meyer, Florence

59037

NOT_YET_RECRUITING

Hôpital Jeanne de Flandre, Lille

69677

NOT_YET_RECRUITING

University and Pediatric Hospital of Lyon, Lyon

75571

NOT_YET_RECRUITING

Hôpital Armand-Trousseau, Paris

98123

NOT_YET_RECRUITING

"Azienda Ospedaliera Universitaria G. Martino", Messina

00161

RECRUITING

Azienda Policlinico Umberto I, Rome

00165

RECRUITING

Ospedale Pediatrico Bambino Gesù, Rome

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alfasigma S.p.A.

INDUSTRY