A Phase 3 interventional study of Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol) in Chronic Constipation, sponsored by Norgine. Completed at 6 sites in United Kingdom. Open to participants aged 24 Months to 11 Years. Per ClinicalTrials.gov, last updated 2006-11-28.
Sponsored by Norgine · Phase 3, Interventional, and Treatment
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
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Norgine is the lead sponsor of 52 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled.
experiencing constipation as defined as:
≤2 complete bowel movements per week, and at least one of the following:
Exclusion Criteria:
Patients will not be eligible to participate in the study if any of the following conditions apply:
Mean number of complete defaecations per week in each treatment period
Mean total number of defaecations (complete plus incomplete) per week in each treatment period
Pain on defaecation
Straining on defaecation
Abdominal pain
Faecal incontinence
Stool consistency
This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.
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