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.
Trial Locations
- Locations (116)
Loma Linda University Health Care
🇺🇸Loma Linda, California, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Arizona Children's Center at Maricopa Medical Center
🇺🇸Phoenix, Arizona, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Monroe Carell Junior Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
University of Alabama Pediatric Gastroenterology
🇺🇸Birmingham, Alabama, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Arkansas Children's Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
Applied Clinical Research of Arkansas
🇺🇸Little Rock, Arkansas, United States
Northwest Arkansas Pediatric Clinic
🇺🇸Fayetteville, Arkansas, United States
Nemours/Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Emmerson Clinical Research
🇺🇸Washington, District of Columbia, United States
MCB Clinical Research
🇺🇸Colorado Springs, Colorado, United States
Palmetto Professional Research
🇺🇸Hialeah, Florida, United States
University of Iowa Children's Hospital
🇺🇸Iowa City, Iowa, United States
Nemours Childrens Clinic
🇺🇸Pensacola, Florida, United States
Children's Center for Digestive Healthcare/GI Care for Kids
🇺🇸Atlanta, Georgia, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
PediaResearch, LLC - Newburgh
🇺🇸Newburgh, Indiana, United States
PediaResearch, LLC - Owensboro
🇺🇸Owensboro, Kentucky, United States
Gastrointestinal Associates, PA
🇺🇸Jackson, Mississippi, United States
Johns Hopkins Children's Center
🇺🇸Baltimore, Maryland, United States
Virgo-Carter Pediatrics
🇺🇸Silver Spring, Maryland, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
NY Presbyterian Weill Cornell
🇺🇸New York, New York, United States
Pioneer Clinical Research
🇺🇸Bellevue, Nebraska, United States
Smart Medical Research, Inc.
🇺🇸Jackson Heights, New York, United States
Morgan Stanley Children's Hospital of New York Presbyterian
🇺🇸New York, New York, United States
PriMed Clinical Research
🇺🇸Beavercreek, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
Children's Hospital of Pittsburgh UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
AAPRI Clinical Research
🇺🇸Warwick, Rhode Island, United States
Coastal Pediatrics Associates - Mount Pleasant
🇺🇸Mount Pleasant, South Carolina, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
3rd Coast Research Associates
🇺🇸Corpus Christi, Texas, United States
Childrens Medical Center Dallas
🇺🇸Dallas, Texas, United States
Bridgerland Clinical Research
🇺🇸Logan, Utah, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Wee Care Pediatrics
🇺🇸Syracuse, Utah, United States
Medical Clinics of Sealy
🇺🇸Sealy, Texas, United States
INOVA Pediatric Digestive Diseases Center
🇺🇸Fairfax, Virginia, United States
MultiCare Health System Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States
Zain Research LLC
🇺🇸Richland, Washington, United States
Northwest Clinicial Research Center
🇺🇸Bellevue, Washington, United States
Universitair Kinderziekenhuis Brussel
🇧🇪Brussel, Belgium
University Hospital Gasthuisberg
🇧🇪Leuven, Belgium
Centre de recherche du CHUS
🇨🇦Sherbrooke, Quebec, Canada
CHC - Clinique Saint-Joseph
🇧🇪Montegnee, Belgium
Sainte Justine University Health Center
🇨🇦Montreal, Canada
Groupe Hospitalier Est
🇫🇷Bron, France
Maasstad Hospital Rotterdam
🇳🇱Rotterdam, Netherlands
CHU-Bordeaux
🇫🇷Bordeaux, France
Emma Children's Hospital
🇳🇱Amsterdam, Netherlands
Hôpital Necker
🇫🇷Paris-Cedex, France
Armand-Trousseau Teaching Hospital
🇫🇷Paris, France
Medical University of Bialystok
🇵🇱Bialystok, Poland
Szpital Uniwersytecki
🇵🇱Bydgoszcz, Poland
Isala Klinieken
🇳🇱Zwolle, Netherlands
ATOPIA Poradnie Specjalistyczne
🇵🇱Krakow, Poland
Medical University of Lodz
🇵🇱Lodz, Poland
Gabinet Lekarski Bartosc Korczowski
🇵🇱Rzeszow, Poland
Children's Memorial Health Institute
🇵🇱Warszaw, Poland
Szpital Pediatryczny ICZMP
🇵🇱Lodz, Poland
Przychodnia Specjalistyczna PROSEN
🇵🇱Warszawa, Poland
Kent and Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, United Kingdom
Darlington Memorial Hospital
🇬🇧Darlington, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Sheffield Children Hospital
🇬🇧Sheffield, United Kingdom
Great Ormond Street Hospital for children NHS Foundation Trust
🇬🇧London, United Kingdom
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
The Children's Hospital of the King's Daughter
🇺🇸Norfolk, Virginia, United States
Pediatric Gastroenterology Carilion Medical Center
🇺🇸Roanoke, Virginia, United States
WCCT Global
🇺🇸Costa Mesa, California, United States
Savin Medical Group Research Center
🇺🇸Miami Lakes, Florida, United States
Square-1 Clinical Research, Inc.
🇺🇸Erie, Pennsylvania, United States
St. Christopher's Hospital for Children/Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Midwest Children's Health Research Institute
🇺🇸Lincoln, Nebraska, United States
Center For Children's Digestive Health
🇺🇸Park Ridge, Illinois, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Envision Clinical Research, LLC
🇺🇸Laredo, Texas, United States
Willis-Knighton Physician Network
🇺🇸Shreveport, Louisiana, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
The Jackson Clinic, P.C.
🇺🇸Jackson, Tennessee, United States
University of South Alabama Women's and Children's Hospital
🇺🇸Mobile, Alabama, United States
Methodist Medical Center
🇺🇸Peoria, Illinois, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Texas Tech University Health Sciences Center
🇺🇸Amarillo, Texas, United States
A1 Clinical Research
🇺🇸Baytown, Texas, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Digestive & Liver Center of Florida
🇺🇸Orlando, Florida, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
UNC School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
🇺🇸Louisville, Kentucky, United States
Coastal Clinical Research
🇺🇸Charleston, South Carolina, United States
Coastal Pediatric Associates - James Island
🇺🇸Charleston, South Carolina, United States
University of Florida
🇺🇸Gainesville, Florida, United States
UnityPoint Health Des Moines/ Blank Children's Clinic
🇺🇸Des Moines, Iowa, United States
Children's Hospital
🇺🇸New Orleans, Louisiana, United States
Austin Center for Clinical Research
🇺🇸Austin, Texas, United States