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

This study has been completed.
Sponsor:
Collaborator:
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT01592734
First received: May 4, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted

May 4, 2012
May 4, 2012
May 2010
November 2011   (final data collection date for primary outcome measure)
  • Efficacy [ Time Frame: 4 weeks of observation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Feacal impaction resolution
Same as current
No Changes Posted
  • Clinical tolerability [ Time Frame: 4 weeks of observation ] [ Designated as safety issue: Yes ]
    Recording of all Adverse Events (AEs) occurred during the study
  • Acceptability [ Time Frame: 4 weeks of observation ] [ Designated as safety issue: No ]
    Palatability and easy of taking the solution evaluated by a 5-points scale
  • Compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Percentage of patients who took more than 80% of the prescribed dose
  • Efficacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Constipation
  • Faecal Impaction
  • Drug: Polyethylene glycol with electrolytes

    Constipation treatment: 1-4 sachets/day according to the patient age. 1 sachet contains 6.9 g PEG-EL. Treatment period: 4 weeks.

    Faecal impaction resolution: 4 sachets as initial dose and increasing 2 sachets a day until resolution or up to 7 days.

    Other Name: Movicol bambini
  • Device: Polyethylene glycol

    Constipation: 0.7 g/kg/day in 2 divided doses for children of less than 20 kg. For children > 20 kg the daily dose was up to PEG 30 g daily. Treatment period: 4 weeks.

    Faecal impaction resolution: 1.5 g/kg/day in 2 doses until resolution or up to 6 days.

    Other Name: Onligol
  • Experimental: PEG-only
    Polyethylene glycol 4000 only (PEG-only).
    Intervention: Device: Polyethylene glycol
  • Active Comparator: PEG-EL
    Polyethylene glycol 3350 with electrolytes (PEG-EL).
    Intervention: Drug: Polyethylene glycol with electrolytes
Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
2 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01592734
PEG-P1
Yes
Giovanni Di Nardo, Azienda Policlinico Umberto I
Azienda Policlinico Umberto I
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Not Provided
Azienda Policlinico Umberto I
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP