An interventional study of Polyethylene glycol 3350 and Placebo in Constipation, sponsored by Line Modin. Completed at 1 site in Denmark. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2016-09-28.
Sponsored by Line Modin · Not applicable, Interventional, and Treatment
Constipation is a common problem among children. The majority of children suffering from constipation have no underlying disease. Although constipation has no basis in underlying disease, it often leads to a reduced quality of life of children who are on par with or worse than for children suffering from serious diseases such as cardiovascular and rheumatic diseases.
Despite the high frequency of constipation among children, little is known about the causes and treatment of constipation.
Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol junior has proven very effective and are therefore widely used in children as disimpaction and maintenance treatment. There is currently no research to prove the need for and length of maintenance treatment with laxative medications in children.
The purpose is to examining the effectiveness of maintenance treatment with Movicol. Additional til study will examine how the anal diameter change during a course of treatment and the degree to which it can be used as an indicator of treatment efficacy.
The study will test the following:
The results from this study are expected to form the basis for an evidence-based approach to the use of maintenance therapy and the use of ultrasound of the rectum in children with constipation.
1,040 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 115 is above the median of 78 across 867 interventional studies indexed under Constipation.
Browse Constipation studies →Line Modin is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Polyethylene glycol 3350
Other: Placebo
Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
Also known as: Movicol, Movicol junior, Moxalole, Lacrofarm
Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
Treatment Recovery
Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.
Time frame: ½ year
Usage of Laxative
Time frame: ½ year
| Milestone | Active Maintenance Treatment | Placebo Maintenance Treatment |
|---|---|---|
| Started | 49 | 53 |
| Completed | 47 | 48 |
| Not completed | 2 | 5 |
Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.
| participants | Active Maintenance Treatment | Placebo Maintenance Treatment |
|---|---|---|
| Treatment Recovery | 33 | 19 |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Maintenance Treatment | — | 1/49 (2%) | 25/49 (51%) |
| Placebo Maintenance Treatment | — | 0/53 (0%) | 32/53 (60.4%) |
| Event | Active Maintenance Treatment | Placebo Maintenance Treatment |
|---|---|---|
| Broken armMusculoskeletal and connective tissue disorders | 1/49 | 0/53 |
| Event | Active Maintenance Treatment | Placebo Maintenance Treatment |
|---|---|---|
| abdominal painGastrointestinal disorders | 6/49 | 22/53 |
| Fever, upper respiratory infektionInfections and infestations | 17/49 | 9/53 |
| BloatingGastrointestinal disorders | 1/49 | 0/53 |
| HeadachNervous system disorders | 1/49 | 1/53 |
| Age, Customized(years) | Active Maintenance Treatment | Placebo Maintenance Treatment | Total |
|---|---|---|---|
| Median | 6.2 (2.5 to 12.3) | 6.1 (2.0 to 15.1) | 6.1 (2.0 to 15.1) |
| Sex: Female, Male(Participants) | Active Maintenance Treatment | Placebo Maintenance Treatment | Total |
|---|---|---|---|
| Female | 18 | 27 | 45 |
| Male | 31 | 26 | 57 |
| Region of Enrollment(participants) | Active Maintenance Treatment | Placebo Maintenance Treatment | Total |
|---|---|---|---|
| Denmark | 49 | 53 | 102 |
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Polyethylene glycol 3350
Line Modin