At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 419 enrolled
Drug / intervention
Lubiprostonedrug
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, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
In Brief
A Phase 3 clinical trial evaluating Lubiprostone for Constipation - Functional. Completed, enrolled 419 participants across 85 sites in 7 countries.
Detailed Summary
This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): * were invited to participate * will receive lubiprostone for 9 more months * will see if lubiprostone safely relieves their constipation if taken for a whole year
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation - Functional
CountriesBelgium, Canada, France, Netherlands, Poland, United Kingdom, United States
CollaboratorsTakeda
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedMay 2014
Primary CompletionMay 2017
TodayJul 2026
First PostedMay 14, 2014
Enrollment StartFeb 26, 2014
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.1 years ago
Interventions
Lubiprostonedrug
12 or 24 mcg soft capsules for oral administration