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

• Status: Completed
• Trial end date: 2016-11-04
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sucampo Pharma Americas, LLC
• Collaborator: Sucampo AG
• Treatments: Lubiprostone

Criteria

Inclusion Criteria:

• Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation

• At least 6 years of age but less than 18 years of age at the time of randomisation

• Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if participant is taking antidepressants

Exclusion Criteria:

• Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation

• Untreated faecal impaction at the time of screening

• Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication