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

• Conditions: constipation; MedDRA version: 12.1Level: LLTClassification code 10010774Term: Constipation

• Registration Number: EUCTR2009-010945-30-IT
• Lead Sponsor: IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified