Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

Completed · Phase 3

Conditions studied: Constipation - Functional

In brief

A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.

Key facts

Study ID

NCT02766777

Run by

Sucampo Pharma Americas, LLC

People needed

87

Starts

2016-04-12

Expected to finish

2016-11-04

Last updated by the study team

2020-05-15

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 participant is taking antidepressants

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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