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Polyethylene Glycol for Childhood Constipation

Primary Purpose

Constipation

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Polyethylene glycol 4000
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, children, polyethylene glycol

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dpt of Pediatrics The Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Polyethylene glycol small dose

Polyethylene glycol high dose

Arm Description

Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks

Polyethylene glycol 4000: 0.7g/kg for 6 weeks

Outcomes

Primary Outcome Measures

therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).

Secondary Outcome Measures

the number of stools delivered at 6th week of intervention
the number of incontinence episodes
the number of painful defecation
the number of episodes of abdominal pain
the number of patients needed laxatives during treatment
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

Full Information

First Posted
June 6, 2013
Last Updated
November 1, 2013
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01875744
Brief Title
Polyethylene Glycol for Childhood Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, children, polyethylene glycol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polyethylene glycol small dose
Arm Type
Experimental
Arm Description
Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks
Arm Title
Polyethylene glycol high dose
Arm Type
Active Comparator
Arm Description
Polyethylene glycol 4000: 0.7g/kg for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol 4000
Other Intervention Name(s)
Forlax
Primary Outcome Measure Information:
Title
therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).
Time Frame
the number and consistency of the stool will be recorded at 6th week of intervention
Secondary Outcome Measure Information:
Title
the number of stools delivered at 6th week of intervention
Time Frame
the number of the stools will be recorded at the 6th week of intervention
Title
the number of incontinence episodes
Time Frame
the number of the incontinence episodes will be recorded at the 6th week of intervention
Title
the number of painful defecation
Time Frame
the number of painful defecation will be recorded at the 6th week of intervention
Title
the number of episodes of abdominal pain
Time Frame
the number of the episodes of abdominal pain will be recorded at the 6th week of intervention
Title
the number of patients needed laxatives during treatment
Time Frame
the number patiens needed laxatives will be recorded for six weeks of intervention
Title
side effects
Description
the number and character of the sides effects will be recorded by the patient at the diary during the 6 weeks of the intervention
Time Frame
the number and the character of the side effects will be recorded for six weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Dziechciarz, MD
Phone
4822-4523292
Email
piotrdz@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Horvath, MD
Phone
4822-4523292
Email
andrea.hania@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Horvath, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt of Pediatrics The Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
01-184
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Dziechciarz, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25162362
Citation
Dziechciarz P, Horvath A, Szajewska H. Polyethylene glycol 4000 for treatment of functional constipation in children. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):65-8. doi: 10.1097/MPG.0000000000000543.
Results Reference
derived

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Polyethylene Glycol for Childhood Constipation

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