Efficacy and Safety of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 6 - 17 |
Updated: | 4/17/2018 |
Start Date: | December 2013 |
End Date: | September 2016 |
A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
A study of the efficacy and safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to <
18 years diagnosed with Functional Constipation
18 years diagnosed 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.
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
We found this trial at
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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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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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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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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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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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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Buffalo, New York 14222
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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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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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