CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 552 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.

Search/NCT03097861
NCT03097861Phase 3Completed
CompareCT.gov

A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation

Sucampo Pharma Americas, LLC·interventional·Posted Mar 31, 2017·Updated Jan 14, 2020

In Brief

A Phase 3 clinical trial evaluating Lubiprostone and Placebo for Chronic Idiopathic Constipation. Completed, enrolled 552 participants across 67 sites.

Detailed Summary

The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Constipation
CountriesUnited States
CollaboratorsSucampo AG, Sucampo Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 31, 2017
Enrollment StartMar 13, 2017
Primary CompletionAug 17, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.3 years ago

Interventions

Lubiprostonedrug

24 mcg administered orally BID

Placebodrug

24 mcg administered orally BID