drugset / Trial / NCT02729909

Lubiprostone for Chronic Idiopathic Constipation Treatment

NCT02729909 ↗

Phase 3 Completed 211 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2016-05-11
Primary completion
2017-04-28
Completion
2017-06-05

Outcome

Met primary endpoint

registry analysis (superiority test); Lubiprostone 24 μg vs Placebo; p = 0.020; Median Value of confidence interval (CI) 1.0 (95% CI 0.1 to 1.9); Van Elteren Test NCT02729909 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lubiprostone Small molecule 24 ug Oral

Indications