drugset / Trial / NCT02651155

Lubiprostone for the Treatment of Chronic Idiopathic Constipation

NCT02651155 ↗

Phase 3 Completed 204 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is 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
2016-03-02
Primary completion
2017-01-11
Completion
2017-01-11

Outcome

Met primary endpoint

registry Placebo vs Lubiprostone 24 μg; p = 0.003; Median Values of CI 1.0 (95% CI 0.1 to 1.0); Van Elteren Test NCT02651155 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lubiprostone Small molecule 24 ug Oral

Indications