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Clinical Trials/EUCTR2009-010945-30-IT
EUCTR2009-010945-30-ITActive, not recruitingNot Applicable

Prospective, Randomized, Controlled, Double Blind Study on the Effectiveness of Movicol (PEG 3350) versus SedaStip (acacia fiber, psyllium fiber (Plantago ovata), fructose) in the Treatment of Chronic Functional Constipation in childhood. - ND

IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II0 sitesStarted: February 1, 2010Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • Age 6 months-18 years Diagnosis of functional constipation according to the criteria of Rome III No therapy rammollitori faecal must have been started during the week before the start of the study All parents or their guardians must sign a document of informed consent indicating their awareness of nature investigazionale and risks of this study. Compliance with the study protocol
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • Inability or unwillingness to give informed consent; Diagnosis of constipation of organic nature; Persons who use or have used in previous 7 days of faecal rammollitori; Delayed emission of meconium in the newborn at term; Presence of any other significant medical condition.

Investigators

Sponsor
IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II

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