CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 87 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.

Search/NCT02766777
NCT02766777Phase 3Completed
CompareCT.gov

A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

Sucampo Pharma Americas, LLC·interventional·Posted May 10, 2016·Updated May 15, 2020

In Brief

A Phase 3 clinical trial evaluating Lubiprostone for Constipation - Functional. Completed, enrolled 87 participants across 13 sites.

Detailed Summary

A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation - Functional
CountriesUnited States
CollaboratorsSucampo AG

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 10, 2016
Enrollment StartApr 12, 2016
Primary CompletionNov 4, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.1 years ago

Interventions

Lubiprostonedrug

12 or 24 mcg soft capsules for oral administration.