NCT02042183

Lubiprostone in Children With Functional Constipation

A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Sucampo Pharma Americas, LLC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Detailed description

Dose administration details: * Participants with a body weight \<50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID. * Participants with a body weight \>50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.

Conditions

• Constipation - Functional

Interventions

Type	Name	Description
DRUG	Lubiprostone	12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
DRUG	Placebo	0 mcg soft capsules of placebo for oral administration

Timeline

• Start date: 2013-12-13
• Primary completion: 2016-07-27
• Completion: 2016-07-27
• First posted: 2014-01-22
• Last updated: 2020-07-21
• Results posted: 2020-07-21

Locations

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

Regulatory

• FDA-regulated drug study