Constipation Clinical Trial
Official title:
Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children. A Controlled Double Blind Randomized Study vs a Standard PEG-EL Laxative
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
Constipation is a very common complaint in childhood. Inadequate daily fiber intake,
insufficient fluid intake, and withholding behavior are considered as factors leading to
constipation.
Painful defecation is considered a common trigger to faecal retention wich leads to
reabsorption of fluids and increase in the size and consistency of stools.
It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based
laxatives are considered today the gold standard for treatment of constipation in children.
PEG formulations differ for composition in inactive ingredients which may have an impact on
acceptance, compliance and adherence to treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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