Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months

PHASE4CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

April 18, 2016

Primary Completion Date

December 31, 2019

Study Completion Date

March 17, 2020

Conditions
Chronic Functional Constipation
Interventions
DEVICE

micro-enema with Promelaxin

The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.

DRUG

Macrogol 4000

Stool softener

Trial Locations (4)

27100

Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19, Pavia

67100

ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito, L’Aquila

80131

Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II, Napoli

80138

"AOU Università degli Studi della Campania Luigi Vanvitelli", Napoli

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Eclisse - Euromed Clinical Supply Services Srl

UNKNOWN

collaborator

Ceinge - Biotecnologie Avanzate s.c. a r.l.

UNKNOWN

collaborator

Latis S.r.l.

INDUSTRY

collaborator

PhAST Consulting Srl

UNKNOWN

lead

Aboca Spa Societa' Agricola

INDUSTRY