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About
A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety of Movicol in the treatment of chronic constipation in children
Full description
After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were entered into the treatment phase of the study. Patients were randomised to receive either Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients underwent a two (2)-week placebo washout period prior to crossing over to receive the alternative treatment e.g. those patients who took Movicol were given the matching Placebo or vice versa on completion of the washout period for two (2) weeks.
On completion of the double blind treatment phase, patients were given the option to participate in the eight (8) week open label post study follow-up. Patients who participated in the post study follow-up received Movicol.
Sex
Ages
Volunteers
Inclusion criteria
Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled.
informed consent having been obtained from the patient's parent or guardian and assent from the child if they are capable of understanding the study
aged 24 months - 11 years
experiencing constipation as defined as:
≤2 complete bowel movements per week, and at least one of the following:
patients in whom these symptoms have been present for ≥3 months
available to complete the study and able to comply with requirements and restrictions listed in the patient's/parent's information documents.
Exclusion criteria
Patients will not be eligible to participate in the study if any of the following conditions apply:
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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