Clinical trial NCT02766777: Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
Official title: A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation - Functional
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Sucampo AG
First posted: 2016-05-10
Enrollment: 87
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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 participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.

Eligibility criteria: 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 participant 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

Primary outcomes:
measure: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: within 25 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Peoria
country: United States
facility: Methodist Medical Center
state: Illinois
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network
state: Louisiana
city: Bellevue
country: United States
facility: Pioneer Clinical Research
state: Nebraska
city: Beavercreek
country: United States
facility: PriMed Clinical Research
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Charleston
country: United States
facility: Coastal Clinical Research
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Pediatrics Associates - Mount Pleasant
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Corpus Christi
country: United States
facility: 3rd Coast Research Associates
state: Texas
city: Logan
country: United States
facility: Bridgerland Clinical Research
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References: