Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
NCT ID: NCT02766777
Last Updated: 2020-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
87 participants
INTERVENTIONAL
2016-04-12
2016-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lubiprostone
Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Lubiprostone
12 or 24 mcg soft capsules for oral administration.
Interventions
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Lubiprostone
12 or 24 mcg soft capsules for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 participant is taking antidepressants
Exclusion Criteria
* 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
6 Years
17 Years
ALL
No
Sponsors
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Sucampo AG
INDUSTRY
Sucampo Pharma Americas, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States
Methodist Medical Center
Peoria, Illinois, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, United States
Pioneer Clinical Research
Bellevue, Nebraska, United States
PriMed Clinical Research
Beavercreek, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
Coastal Clinical Research
Charleston, South Carolina, United States
Coastal Pediatrics Associates - Mount Pleasant
Mt. Pleasant, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
3rd Coast Research Associates
Corpus Christi, Texas, United States
Bridgerland Clinical Research
Logan, Utah, United States
Wee Care Pediatrics
Syracuse, Utah, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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SCMP-0211-303
Identifier Type: -
Identifier Source: org_study_id
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