Lubiprostone in Children With Functional Constipation
- Registration Number
- NCT02042183
- Lead Sponsor
- Sucampo Pharma Americas, LLC
- Brief Summary
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 606
- 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 subject is taking antidepressants
- Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lubiprostone Lubiprostone Participants receive lubiprostone twice daily (BID) up to 12 weeks Placebo Placebo Participants receive placebo BID up to 12 weeks
- Primary Outcome Measures
Name Time Method Number of Participants Classified as Overall Responders at Week 12 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.
- Secondary Outcome Measures
Name Time Method Mean Number of SBMs Observed Each Week for 12 Weeks within 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.
Related Research Topics
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Trial Locations
- Locations (116)
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
Scroll for more (106 remaining)University of Alabama Pediatric Gastroenterology🇺🇸Birmingham, Alabama, United States