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
Drug: Polyethylene glycol with electrolytes
Device: Polyethylene glycol
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Full eligibility criteria for NCT01592734
Ages eligible for Study
2 Years to 16 Years
Genders eligible for Study
Accepts Healthy Volunteers
out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination
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
All locations for NCT01592734
View full eligibility
Tris trial is registered with FDA with number: NCT01592734. The sponsor of the trial is Azienda Policlinico Umberto I and it is looking for 96 volunteers for the current phase.
Official trial 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
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