Lubiprostone in Children With Functional Constipation

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02042183
Study type	Interventional
Source	Mallinckrodt
Contact
Status	Completed
Phase	Phase 3
Start date	December 13, 2013
Completion date	July 27, 2016

View Details

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