Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
606 participants
INTERVENTIONAL
2013-12-13
2016-07-27
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lubiprostone
Participants receive lubiprostone twice daily (BID) up to 12 weeks
Lubiprostone
12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
Placebo
Participants receive placebo BID up to 12 weeks
Placebo
0 mcg soft capsules of placebo for oral administration
Interventions
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Lubiprostone
12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
Placebo
0 mcg soft capsules of placebo for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
6 Years
17 Years
ALL
No
Sponsors
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Sucampo AG
INDUSTRY
Sucampo Pharma Americas, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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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
Children's Hospital of Orange County
Orange, California, United States
University of California, San Francisco
San Francisco, California, United States
MCB Clinical Research
Colorado Springs, Colorado, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Emmerson Clinical Research
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Palmetto Professional Research
Hialeah, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Savin Medical Group Research Center
Miami Lakes, Florida, United States
Digestive & Liver Center of Florida
Orlando, Florida, United States
Nemours Childrens Clinic
Pensacola, Florida, United States
Children's Center for Digestive Healthcare/GI Care for Kids
Atlanta, Georgia, United States
Center For Children's Digestive Health
Park Ridge, Illinois, United States
Methodist Medical Center
Peoria, Illinois, United States
PediaResearch, LLC - Newburgh
Newburgh, Indiana, United States
UnityPoint Health Des Moines/ Blank Children's Clinic
Des Moines, Iowa, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Heartland Research Associates
Wichita, Kansas, United States
University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
PediaResearch, LLC - Owensboro
Owensboro, Kentucky, United States
Children's Hospital
New Orleans, Louisiana, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, 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
Mayo Clinic
Rochester, Minnesota, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
Pioneer Clinical Research
Bellevue, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo
Buffalo, New York, United States
Smart Medical Research, Inc.
Jackson Heights, New York, United States
NY Presbyterian Weill Cornell
New York, New York, United States
Morgan Stanley Children's Hospital of New York Presbyterian
New York, New York, United States
UNC School of Medicine
Chapel Hill, North Carolina, United States
PriMed Clinical Research
Beavercreek, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Cyn3rgy Research
Gresham, Oregon, United States
Square-1 Clinical Research, Inc.
Erie, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children/Drexel University
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States
AAPRI Clinical Research
Warwick, Rhode Island, United States
Coastal Pediatric Associates - James Island
Charleston, South Carolina, United States
Coastal Clinical Research
Charleston, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Coastal Pediatrics Associates - Mount Pleasant
Mt. Pleasant, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
The Jackson Clinic, P.C.
Jackson, Tennessee, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Monroe Carell Junior Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center
Amarillo, Texas, United States
Austin Center for Clinical Research
Austin, Texas, United States
A1 Clinical Research
Baytown, Texas, United States
3rd Coast Research Associates
Corpus Christi, Texas, United States
Childrens Medical Center Dallas
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Envision Clinical Research, LLC
Laredo, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Medical Clinics of Sealy
Sealy, Texas, United States
Bridgerland Clinical Research
Logan, Utah, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Wee Care Pediatrics
Syracuse, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
INOVA Pediatric Digestive Diseases Center
Fairfax, 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
Northwest Clinicial Research Center
Bellevue, Washington, United States
Zain Research LLC
Richland, Washington, United States
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Universitair Kinderziekenhuis Brussel
Brussels, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
CHC - Clinique Saint-Joseph
Montegnée, , Belgium
London Health Sciences Centre
London, Ontario, Canada
Centre de recherche du CHUS
Sherbrooke, Quebec, Canada
Sainte Justine University Health Center
Montreal, , Canada
CHU-Bordeaux
Bordeaux, , France
Groupe Hospitalier Est
Bron, , France
Armand-Trousseau Teaching Hospital
Paris, , France
Hôpital Necker
Paris, , France
Emma Children's Hospital
Amsterdam, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Maasstad Hospital Rotterdam
Rotterdam, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Medical University of Bialystok
Bialystok, , Poland
Szpital Uniwersytecki
Bydgoszcz, , Poland
ATOPIA Poradnie Specjalistyczne
Krakow, , Poland
Medical University of Lodz
Lodz, , Poland
Szpital Pediatryczny ICZMP
Lodz, , Poland
Gabinet Lekarski Bartosc Korczowski
Rzeszów, , Poland
Children's Memorial Health Institute
Warsaw, , Poland
Przychodnia Specjalistyczna PROSEN
Warsaw, , Poland
Children's Memorial Health Institute
Warsaw, , Poland
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Darlington Memorial Hospital
Darlington, , United Kingdom
Royal Hospital for Sick Children
Glasgow, , United Kingdom
Royal London Hospital
London, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Great Ormond Street Hospital for children NHS Foundation Trust
London, , United Kingdom
Sheffield Children Hospital
Sheffield, , United Kingdom
Countries
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References
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Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7.
Other Identifiers
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2013-004384-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMEA-000245-PIP01-08
Identifier Type: OTHER
Identifier Source: secondary_id
SAG/0211PFC-1131
Identifier Type: -
Identifier Source: org_study_id
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