Evaluation of the 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:April 2016
End Date:November 2016

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A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

A study of the safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to < 18 years
diagnosed with Functional Constipation

To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules
dosed twice daily (BID) when administered orally for 24 weeks in pediatric subjects with
functional constipation. Evaluation of lubiprostone safety and tolerability is the primary
objective in this study.

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, 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
13
sites
1952 Long Grove Drive
Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
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Spartanburg, SC
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Beavercreek, Ohio 45431
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Beavercreek, OH
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Bellevue, Nebraska 68005
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Bellevue, NE
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Charleston, South Carolina 29414
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Charleston, SC
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Charlottesville, Virginia 22902
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Charlottesville, VA
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Corpus Christi, Texas 78414
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Corpus Christi, TX
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Fayetteville, Arkansas 72703
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Fayetteville, AR
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Gresham, Oregon 97030
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Gresham, OR
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Logan, Utah 84341
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Logan, UT
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Peoria, Illinois 61602
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Peoria, IL
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Shreveport, Louisiana 71118
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Shreveport, LA
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Syracuse, Utah 84075
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Syracuse, UT
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