CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 164 enrolled
Drug / intervention
Lubiprostone +1 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/NCT01993875
NCT01993875Phase 3Completed
CompareCT.gov

A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

Mallinckrodt·interventional·Posted Nov 25, 2013·Updated Dec 13, 2019

In Brief

A Phase 3 clinical trial evaluating Lubiprostone and Placebo for Chronic Idiopathic Constipation. Completed, enrolled 164 participants across 11 sites.

Detailed Summary

To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Constipation
CountriesUnited States
CollaboratorsSucampo Pharma Americas, LLC, Takeda, Sucampo AG

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartOct 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.6 years ago

Interventions

Lubiprostonedrug

Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)

Placebodrug

Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)