Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
419 participants
INTERVENTIONAL
2014-02-26
2017-05-01
Brief Summary
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Children who completed 3 months of treatment in the earlier study (NCT02042183):
* were invited to participate
* will receive lubiprostone for 9 more months
* will see if lubiprostone safely relieves their constipation if taken for a whole year
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lubiprostone
Participants receive lubiprostone twice daily
Participants must have completed the entire 12-week treatment period during the preceding study. Those who received 12 mcg twice daily (BID) continued to receive 12 mcg, those who received 24 mcg BID continued with that dose.Those of the placebo arm in the previous study weighing less than 50 kg received 12 mcg BID and over 50 kg received 24 mcg BID during this study.
Lubiprostone
12 or 24 mcg soft capsules for oral administration
Interventions
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Lubiprostone
12 or 24 mcg soft capsules for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility
Exclusion Criteria
* Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease
* Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)
6 Years
17 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Sucampo Pharma Americas, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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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 Childrens Hospital Research Institute
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
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
Nemours Childrens Clinic
Pensacola, Florida, United States
Children's Center for Digestive Health Care/GI Care for Kids
Atlanta, Georgia, 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
Willis-Knighton Physician Network
Shreveport, Louisiana, United States
Virgo-Carter Pediatrics
Silver Spring, Maryland, 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
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
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
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
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
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
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
CHC - Clinique Saint-Joseph
Montegnée, , Belgium
Sainte Justine University Health Center
Montreal, , Canada
CHU-Bordeaux
Bordeaux, , 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
Szpital Pediatryczny ICZMP
Lodz, , Poland
Gabinet Lekarski Bartosc Korczowski
Rzeszów, , Poland
Przychodnia Specjalistyczna PROSEN
Warsaw, , Poland
Children's Memorial Health Institute
Warsaw, , Poland
Darlington Memorial Hospital
Darlington, , United Kingdom
Royal London Hospital
London, , United Kingdom
Chelsea and Westminster Hospital 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2013-004384-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SAG-0211PFC-11S1
Identifier Type: -
Identifier Source: org_study_id
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