drugset / Trial / NCT02695719

Lubiprostone for Treatment of Chronic Idiopathic Constipation

NCT02695719 ↗

Phase 3 Completed 156 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of oral administration of lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.

Timeline

Start
2016-04-14
Primary completion
2017-01-20
Completion
2017-02-24

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Lubiprostone 24 μg; p = 0.007; Median Values of CI 1.0 (95% CI 0.1 to 1.9); Van Elteren Test NCT02695719 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lubiprostone Small molecule 24 ug Oral

Indications