Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sucampo Pharma Americas, LLC
With
Sucampo AG
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.
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
