Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children
|Constipation Faecal Impaction||Drug: Polyethylene glycol with electrolytes Device: Polyethylene glycol||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|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|
- 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
- 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
|Study Start Date:||May 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Polyethylene glycol 4000 only (PEG-only).
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
Active Comparator: PEG-EL
Polyethylene glycol 3350 with electrolytes (PEG-EL).
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
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.