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

The purpose of this study is to assess the long-term safety, efficacy, and pharmacokinetics
of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) when administered orally
for 36 weeks in paediatric subjects with functional constipation.

Inclusion Criteria:

- Completed 12 weeks of blinded treatment in the SAG/0211PFC-1131 study.

- Continue to abstain from taking concomitant medication (prescribed or
over-the-counter) that affects gastrointestinal motility.

Exclusion Criteria:

- Untreated faecal impaction at the time of rolling over into study.

- Significant change in medical status, newly diagnosed and uncontrolled cardiovascular,
liver or lung disease, neurologic or psychiatric disorder, or other systemic disease.

- Demonstrated non-compliance with study protocol during the SAG/0211PFC-1131 study.