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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Policlinico Umberto I
• Collaborator: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Treatments: Cathartics; Laxatives

Criteria

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