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
Macrogol (Transipeg, BAY81-8430)
+ Macrogol (Forlax)
Signs and Symptoms+1
+ Signs and Symptoms, Digestive
+ Pathological Conditions, Signs and Symptoms
Treatment Study
Summary
Study start date: April 1, 2006
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.97 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 6 Months to 15 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations