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 |
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
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.
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.
We found this trial at
68
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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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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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Louisville, Kentucky 40202
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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1952 Long Grove Drive
Mount Pleasant, South Carolina 29464
Mount Pleasant, South Carolina 29464
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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