Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
Dose administration details: * Participants with a body weight \<50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID. * Participants with a body weight \>50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
606
12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
0 mcg soft capsules of placebo for oral administration
Number of Participants Classified as Overall Responders at Week 12
An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.
Time frame: at Week 12
Mean Number of SBMs Observed Each Week for 12 Weeks
Data provided is based on observed cases. Baseline is the average of the 2 weeks before being randomized. Participants are summarized by actual dose received after week 1.
Time frame: within 12 Weeks
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University of Alabama Pediatric Gastroenterology
Birmingham, Alabama, United States
University of South Alabama Women's and Children's Hospital
Mobile, Alabama, United States
Arizona Children's Center at Maricopa Medical Center
Phoenix, Arizona, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Applied Clinical Research of Arkansas
Little Rock, Arkansas, United States
WCCT Global
Costa Mesa, California, United States
Loma Linda University Health Care
Loma Linda, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
...and 107 more locations