CompletedPhase 4

Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children

96 participantsStarted 2010-05

Plain-language summary

The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation

Who can participate

Age range2 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination Exclusion Criteria: * children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities; * Children receiving medication influencing gastrointestinal motility; * Children with suspected gastrointestinal obstruction or stenosis

What they're measuring

Efficacy

Timeframe: 4 weeks of observation

Efficacy

Timeframe: 7 days

Trial details

NCT IDNCT01592734

SponsorAzienda Policlinico Umberto I

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-11

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