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Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

Constipation - Functional Clinical Trial

Official title:
A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

Clinical Trial Summary

A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.

Clinical Trial Description

To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02766777
Study type Interventional
Source Mallinckrodt
Contact
Status Completed
Phase Phase 3
Start date April 12, 2016
Completion date November 4, 2016
View Details
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