Lubiprostone in Children With Functional Constipation

• Status: Completed
• Trial end date: 2016-07-27
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Sucampo AG; Sucampo Pharma Americas, LLC
• Collaborators: Sucampo AG; Sucampo Pharma Americas, LLC; Takeda
• 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 subject is taking antidepressants

Exclusion Criteria:

• Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), 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