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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Kolding Sygehus | OTHER |
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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:
• What is the effect of maintenance treatment with PEG compared to placebo?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active maintenance treatment | Active Comparator |
| |
| Placebo maintenance treatment | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol 3350 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Recovery | Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria. | ½ year |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of Laxative | ½ year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Line Modin | Kolding | 6000 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Maintenance Treatment | Polyethylene glycol 3350: 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. |
| FG001 | Placebo Maintenance Treatment | Placebo: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Maintenance Treatment | Polyethylene glycol 3350: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Recovery | Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria. | Posted | Number | participants | ½ year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Maintenance Treatment | Polyethylene glycol 3350: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken arm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Line Modin | Pediatric Department, Hospital Lillebaelt, Kolding | 0045 61386349 | line.modin@rsyd.dk |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
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|
|
| Placebo | Other | 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. |
|
| BG001 |
| Placebo Maintenance Treatment |
Placebo: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Usage of Laxative | Not Posted | ½ year |
| 1 |
| 49 |
| 25 |
| 49 |
| EG001 | Placebo Maintenance Treatment | Placebo: 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. | 0 | 53 | 32 | 53 |
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Fever, upper respiratory infektion | Infections and infestations | Systematic Assessment |
|
| Headach | Nervous system disorders | Systematic Assessment |
|
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