At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 606 enrolled
Drug / intervention
Lubiprostone +1 moredrug
Likely dose
Lubiprostone 24 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
In Brief
A Phase 3 clinical trial evaluating Lubiprostone and Placebo for Constipation - Functional. Completed, enrolled 606 participants across 117 sites in 7 countries.
Detailed Summary
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation - Functional
CountriesBelgium, Canada, France, Netherlands, Poland, United Kingdom, United States
CollaboratorsSucampo AG
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedJan 2014
Primary CompletionJul 2016
TodayJul 2026
First PostedJan 22, 2014
Enrollment StartDec 13, 2013
Primary CompletionJul 27, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.4 years ago
Interventions
Lubiprostonedrug
12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
Placebodrug
0 mcg soft capsules of placebo for oral administration