NCT02766777

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Sucampo Pharma Americas, LLC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Constipation - Functional

Interventions

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

Timeline

• Start date: 2016-04-12
• Primary completion: 2016-11-04
• Completion: 2016-11-04
• First posted: 2016-05-10
• Last updated: 2020-05-15
• Results posted: 2020-05-15

Locations

13 sites across 1 country: United States