Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children
1 other identifier
interventional
96
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 7, 2012
CompletedMay 7, 2012
May 1, 2012
1.5 years
May 4, 2012
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy
Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card
4 weeks of observation
Efficacy
Feacal impaction resolution
7 days
Secondary Outcomes (4)
Clinical tolerability
4 weeks of observation
Acceptability
4 weeks of observation
Compliance
4 weeks
Efficacy
4 weeks
Study Arms (2)
PEG-only
EXPERIMENTALPolyethylene glycol 4000 only (PEG-only).
PEG-EL
ACTIVE COMPARATORPolyethylene glycol 3350 with electrolytes (PEG-EL).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 23152962DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 4, 2012
First Posted
May 7, 2012
Study Start
May 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
May 7, 2012
Record last verified: 2012-05