A study of the safety of lubiprostone in pediatric participants 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 participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
12 or 24 mcg soft capsules for oral administration.
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States
Methodist Medical Center
Peoria, Illinois, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, United States
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.
Time frame: within 25 weeks
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