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



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:6 - 17
Updated:12/2/2017
Start Date:March 2014
End Date:August 2017

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A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

A study of the long-term safety and efficacy of Lubiprostone in subjects aged ≥ 6 to < 18
years diagnosed 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.
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
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700 Childrens Drive
Columbus, Ohio 43205
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Gainesville, Florida 32610
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1200 Moursund Street
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2500 N State St
Jackson, Mississippi 39216
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2401 Gillham Rd
Kansas City, Missouri 64108
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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707 Hollybrook Drive
Longview, Texas 75605
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
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485 Simuel Road.
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1935 Medical District Dr
Dallas, Texas 75235
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801 7th Avenue
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8701 W Watertown Plank Rd
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