CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 127 enrolled
Drug / intervention
Lubiprostone +2 moredrug
Likely dose
Lubiprostone 12 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/NCT00452335
NCT00452335Phase 4Completed
CompareCT.gov

A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation

Sucampo Pharma Americas, LLC·interventional·Posted Mar 27, 2007·Updated Dec 17, 2019

In Brief

A Phase 4 clinical trial evaluating Lubiprostone for Constipation. Completed, enrolled 127 participants across 19 sites.

Detailed Summary

The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
CollaboratorsSucampo Pharmaceuticals, Inc.

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2007
Enrollment StartJan 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.3 years ago

Interventions

Lubiprostonedrug

12 mcg capsule once daily (QD)

Lubiprostonedrug

12 mcg capsule twice daily (BID)

Lubiprostonedrug

24 mcg capsule twice daily (BID)