A study of the long-term safety and efficacy of Lubiprostone in subjects aged ≥ 6 to < 18 years diagnosed with Functional Constipation
A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric 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.
Constipation - FunctionalLubiprostone
You can join if…
Open to people ages 6–17
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.
You CAN'T join if...
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.
University of California, San Francisco San Francisco, California, 94143, United States
Children's Hospital Los Angeles Los Angeles, California, 90027, United States
Loma Linda University Health Care Loma Linda, California, 92350, United States
WCCT Global Costa Mesa, California, 92626, United States