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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 La

Brief 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

Detailed Summary:

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.

Sponsor: Azienda Policlinico Umberto I

Current Primary Outcome:

• Efficacy [ Time Frame: 4 weeks of observation ]
  Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card
• Efficacy [ Time Frame: 7 days ]
  Feacal impaction resolution

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Clinical tolerability [ Time Frame: 4 weeks of observation ]
  Recording of all Adverse Events (AEs) occurred during the study
• Acceptability [ Time Frame: 4 weeks of observation ]
  Palatability and easy of taking the solution evaluated by a 5-points scale
• Compliance [ Time Frame: 4 weeks ]
  Percentage of patients who took more than 80% of the prescribed dose
• Efficacy [ Time Frame: 4 weeks ]
  Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card

Original Secondary Outcome: Same as current

Information By: Azienda Policlinico Umberto I

Dates:
Date Received: May 4, 2012
Date Started: May 2010
Date Completion:
Last Updated: May 4, 2012
Last Verified: May 2012