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

NCT02751411 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2020-05-29

No results posted yet for this study

Summary

The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-

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

Sponsors & Collaborators

  • Eclisse - Euromed Clinical Supply Services Srl

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Latis S.r.l.

    collaborator INDUSTRY

  • PhAST Consulting Srl

    collaborator UNKNOWN

  • Aboca Spa Societa' Agricola

    lead INDUSTRY

Principal Investigators

  • Annamaria Staiano, Prof. · Universita Federico II - Pediatric Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-18
Primary Completion
2019-12-31
Completion
2020-03-17

Countries

  • Italy

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 NCT02751411 on ClinicalTrials.gov