Efficacy and Safety of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

To assess the efficacy, safety, and pharmacokinetics (PK) of oral lubiprostone 12 or 24 mcg
capsules dosed twice daily (BID) (based on subject body weight at baseline) as compared to
matching placebo BID, when administered orally for 12 weeks in pediatric subjects with
functional constipation.

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