ConstipationPhase 4NCT01875744
Polyethylene Glycol for Childhood Constipation
A Phase 4 study testing Polyethylene glycol 4000 in people with Constipation, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Constipation
- What is being tested?
- Polyethylene glycol 4000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2013to 30 Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 1 - 18 age
- functional constipation according to the Rome III Criteria
- consent of parents or guardians of the child to participate and study
Who cannot join
- organic cause constipation (including surgeries within the lower GI tract)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Constipation
- Being tested
- Polyethylene glycol 4000
- Keywords
- constipation, children, polyethylene glycol
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol 4000Drug
Also called Forlax
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol small dose | Experimental | Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks Receives: Drug: Polyethylene glycol 4000 |
| Polyethylene glycol high dose | Active comparator | Polyethylene glycol 4000: 0.7g/kg for 6 weeks Receives: Drug: Polyethylene glycol 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).
Measured: the number and consistency of the stool will be recorded at 6th week of intervention
Secondary outcomes (6)
the number of stools delivered at 6th week of intervention
Measured: the number of the stools will be recorded at the 6th week of intervention
the number of incontinence episodes
Measured: the number of the incontinence episodes will be recorded at the 6th week of intervention
the number of painful defecation
Measured: the number of painful defecation will be recorded at the 6th week of intervention
the number of episodes of abdominal pain
Measured: the number of the episodes of abdominal pain will be recorded at the 6th week of intervention
the number of patients needed laxatives during treatment
Measured: the number patiens needed laxatives will be recorded for six weeks of intervention
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
Measured: the number and the character of the side effects will be recorded for six weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completion30 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Horvath-Stolarczyk, Medical University of Warsaw
- Investigators
- Andrea Horvath, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875744
- Sponsor's protocol ID
- 2/2013
- Other IDs
- 2/2013
- Status last verified
- Jul 2025
- First submitted
- 6 Jun 2013
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25162362
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyethylene Glycol for Childhood Constipation
- ClinicalTrials.gov ID
- NCT01875744
- Acronym / sponsor ID
- 2/2013
- Conditions
- Constipation
- Keywords
- constipation, children, polyethylene glycol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol small dose | Experimental | Drug: Polyethylene glycol 4000Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks |
| Polyethylene glycol high dose | Active comparator | Drug: Polyethylene glycol 4000Polyethylene glycol 4000: 0.7g/kg for 6 weeks |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 1 - 18 age
- functional constipation according to the Rome III Criteria
- consent of parents or guardians of the child to participate and study
Key exclusion criteria (1 listed)
- organic cause constipation (including surgeries within the lower GI tract)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene glycol 4000Also: Forlax | Drug | Polyethylene glycol high dose, Polyethylene glycol small dose |
Primary outcome
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
6 secondary outcomes
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
the number of incontinence episodes
Time frame: the number of the incontinence episodes will be recorded at the 6th week of intervention
the number of painful defecation
Time frame: the number of painful defecation will be recorded at the 6th week of intervention
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
the number of patients needed laxatives during treatment
Time frame: the number patiens needed laxatives will be recorded for six weeks of intervention
side effects
Time frame: the number and the character of the side effects will be recorded for six weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 25162362Dziechciarz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Horvath, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene glycol 4000 in people with Constipation, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.