NCT02138136

Lubiprostone for Children With Constipation

A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 419 (actual)
• Sponsor: Sucampo Pharma Americas, LLC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): * were invited to participate * will receive lubiprostone for 9 more months * will see if lubiprostone safely relieves their constipation if taken for a whole year

Conditions

• Constipation - Functional

Interventions

Type	Name	Description
DRUG	Lubiprostone	12 or 24 mcg soft capsules for oral administration

Timeline

• Start date: 2014-02-26
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-05-14
• Last updated: 2020-01-21
• Results posted: 2020-01-21

Locations

85 sites across 7 countries: United States, Belgium, Canada, France, Netherlands, Poland, United Kingdom

Regulatory

• FDA-regulated drug study