A Study to Compare the Effect of Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation

Study Overview
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Brief Summary
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The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits were used for the comparison of long-term safety between the groups.

Official Title
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A Double-blind, Randomized, Uninational, Multicenter, Two Parallel Groups, Active Controlled Study to Compare the Effect of the Treatment With Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation

Conditions
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Constipation

Intervention / Treatment
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* Drug: Macrogol (Transipeg, BAY81-8430)
* Drug: Macrogol (Forlax)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Childhood functional constipation 6 months to <16 years of age Male or female For females of childbearing potential (after menarche): negative pregnancy test Moderately severe to severe constipation, defined as stool frequency <3 stools/week Informed consent signed by parent(s) or legal acceptable representative(s), after sufficient oral and written information before entering the study, to be documented by the investigators in the Case Report Form Exclusion Criteria: Functional non-retentive fecal incontinence Known metabolic or endocrine disorders (s.a. hypothyroidism) Neurologic disorders (s.a. spina bifida or spinal cord anomaly) Hirschsprung's disease (congenital megacolon) Anal anomaly Gastrointestinal surgery Drug induced constipation Mental retardation Cerebral palsy Treatment with other laxatives Drugs influencing gastrointestinal function (e.g., cisapride, erythromicin, imodium) Prior bowel surgery, except appendectomy Earlier participation in this trial Concurrent participation in any other clinical trial Participation in any other clinical study 6 months prior to inclusion Any use of a Macrogol within 2 months prior to inclusion

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macrogol (Transipeg)<br> | Drug: Macrogol (Transipeg, BAY81-8430)<br>* Up to 4 sachets per day based on individual titration<br>|
| Active Comparator: Macrogol (Forlax)<br> | Drug: Macrogol (Forlax)<br>* Up to 4 sachets per day based on individual titration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks |  | Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52 | 
| Change From Baseline in Total Sum Score (TSS) at Week 52 |  | Baseline, Week 52 | 
| Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline |  | Average of Weeks 1 to 8 | 
| Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline |  | Average of Weeks 26 and 52 | 
| Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline |  | Average up to 52 weeks | 
| Dose Range Determination: Mean Dose Based on Sachets Used |  | Up to 52 weeks. | 
| Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used |  | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Treatment Success |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Defecation Frequency |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Consistency of the Feces |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Strains During Defecation |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Quantity of Stools |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Percentage of Subjects With Pain During Defecation |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Frequency of Pain (Times per Week) |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Percentage of Subjects With Abdominal Pain |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Frequency of Abdominal Pain (Times per Week) |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Relation of Abdominal Pain With Defecation |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Percentage of Subjects With Urgency for Defecation |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Frequency of Urgency for Defecation (Times per Week) |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week) |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite |  | Week 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Average Score for Diary Reported Diarrhoea |  | Week 0, 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Average Score for Diary Reported Flatulence |  | Week 0, 1, 2, 4, 8, 12, 26, 52 | 
| Individual Symptoms: Average Score for Diary Reported Nausea |  | Week 0, 1, 2, 4, 8, 12, 26, 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macrogol