Polyethylene Glycol for Childhood Constipation

Constipation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01875744
• Other study ID #: 2/2013
• Secondary ID: 2/2013
• Status: Recruiting
• Phase: Phase 4
• First received: June 6, 2013
• Last updated: November 1, 2013
• Start date: June 2013

Study information

• Verified date: November 2013
• Source: Medical University of Warsaw
• Contact: Piotr Dziechciarz, MD
• Phone: 4822-4523292
• Email: piotrdz[@]hotmail.com
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Background:

Aim:

Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the maintenance treatment of functional constipation in children.

Study design:

Randomized, open-label trial.

Randomized, double-blind, placebo controlled trial.

Description:

Children will be randomly assigned into 2 groups receiving polyethylene glycol 4000 (Forlax) with an initial dose of either 0.3g/kg, or 0.7 g / kg.

In case of ineffectiveness the dose of medication will be increased every two weeks with 0.2 g/kg. The indication for the increase in dose will be less than 3 bowel movements per week. For children with diarrhea defined as more than 3 loose stools for minimum 2 days or/and severe abdominal pain the macrogol dose of will be reduced every two weeks by 0.2 g/kg. The intervention will last 6 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• age 1 - 18 age

• functional constipation according to the Rome III Criteria

• consent of parents or guardians of the child to participate and study

Exclusion Criteria:

• organic cause constipation (including surgeries within the lower GI tract)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Polyethylene glycol 4000

Locations

Country	Name	City	State
Poland	Dpt of Pediatrics The Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	therapeutic success (passing = 3 stools per week, with no loosening of stool).		the number and consistency of the stool will be recorded at 6th week of intervention	No
Secondary	the number of stools delivered at 6th week of intervention		the number of the stools will be recorded at the 6th week of intervention	No
Secondary	the number of incontinence episodes		the number of the incontinence episodes will be recorded at the 6th week of intervention	No
Secondary	the number of painful defecation		the number of painful defecation will be recorded at the 6th week of intervention	No
Secondary	the number of episodes of abdominal pain		the number of the episodes of abdominal pain will be recorded at the 6th week of intervention	No
Secondary	the number of patients needed laxatives during treatment		the number patiens needed laxatives will be recorded for six weeks of intervention	No
Secondary	side effects	the number and character of the sides effects will be recorded by the patient at the diary during the 6 weeks of the intervention	the number and the character of the side effects will be recorded for six weeks of intervention	Yes