Lubiprostone in Children With Functional Constipation
A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
3 other identifiers
interventional
606
7 countries
117
Brief Summary
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2013
Typical duration for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2013
CompletedFirst Submitted
Initial submission to the registry
January 17, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2016
CompletedResults Posted
Study results publicly available
July 21, 2020
CompletedJuly 21, 2020
July 1, 2020
2.6 years
January 17, 2014
May 4, 2020
July 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
at Week 12
Secondary Outcomes (1)
Mean Number of SBMs Observed Each Week for 12 Weeks
within 12 Weeks
Study Arms (2)
Lubiprostone
EXPERIMENTALParticipants receive lubiprostone twice daily (BID) up to 12 weeks
Placebo
PLACEBO COMPARATORParticipants receive placebo BID up to 12 weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sucampo Pharma Americas, LLClead
- Sucampo AGcollaborator
Study Sites (117)
University of Alabama Pediatric Gastroenterology
Birmingham, Alabama, 35233, United States
University of South Alabama Women's and Children's Hospital
Mobile, Alabama, 36604, United States
Arizona Children's Center at Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Applied Clinical Research of Arkansas
Little Rock, Arkansas, 72212, United States
WCCT Global
Costa Mesa, California, 92626, United States
Loma Linda University Health Care
Loma Linda, California, 92350, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
University of California, San Francisco
San Francisco, California, 94143, United States
MCB Clinical Research
Colorado Springs, Colorado, 80910, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Emmerson Clinical Research
Washington D.C., District of Columbia, 20020, United States
University of Florida
Gainesville, Florida, 32610, United States
Palmetto Professional Research
Hialeah, Florida, 33016, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Acevedo Clinical Research Associates
Miami, Florida, 33142, United States
Savin Medical Group Research Center
Miami Lakes, Florida, 33014, United States
Digestive & Liver Center of Florida
Orlando, Florida, 32819, United States
Nemours Childrens Clinic
Pensacola, Florida, 32504, United States
Children's Center for Digestive Healthcare/GI Care for Kids
Atlanta, Georgia, 30342, United States
Center For Children's Digestive Health
Park Ridge, Illinois, 60068, United States
Methodist Medical Center
Peoria, Illinois, 61602, United States
PediaResearch, LLC - Newburgh
Newburgh, Indiana, 47630, United States
UnityPoint Health Des Moines/ Blank Children's Clinic
Des Moines, Iowa, 50309, United States
University of Iowa Children's Hospital
Iowa City, Iowa, 52242, United States
Heartland Research Associates
Wichita, Kansas, 67205, United States
University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202, United States
PediaResearch, LLC - Owensboro
Owensboro, Kentucky, 42301, United States
Children's Hospital
New Orleans, Louisiana, 70118, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, 71101, United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287, United States
Virgo-Carter Pediatrics
Silver Spring, Maryland, 20910, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64145, United States
Pioneer Clinical Research
Bellevue, Nebraska, 68005, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504, United States
Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo
Buffalo, New York, 14222, United States
Smart Medical Research, Inc.
Jackson Heights, New York, 11372, United States
NY Presbyterian Weill Cornell
New York, New York, 10021, United States
Morgan Stanley Children's Hospital of New York Presbyterian
New York, New York, 10032, United States
UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
PriMed Clinical Research
Beavercreek, Ohio, 45431, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Toledo Children's Hospital
Toledo, Ohio, 43606, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Square-1 Clinical Research, Inc.
Erie, Pennsylvania, 16506, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hospital for Children/Drexel University
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15224, United States
AAPRI Clinical Research
Warwick, Rhode Island, 02886, United States
Coastal Pediatric Associates - James Island
Charleston, South Carolina, 29412, United States
Coastal Clinical Research
Charleston, South Carolina, 29414, United States
Greenville Health System
Greenville, South Carolina, 29615, United States
Coastal Pediatrics Associates - Mount Pleasant
Mt. Pleasant, South Carolina, 29464, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
The Jackson Clinic, P.C.
Jackson, Tennessee, 38305, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105, United States
Monroe Carell Junior Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Texas Tech University Health Sciences Center
Amarillo, Texas, 79106, United States
Austin Center for Clinical Research
Austin, Texas, 78756, United States
A1 Clinical Research
Baytown, Texas, 77521, United States
3rd Coast Research Associates
Corpus Christi, Texas, 78413, United States
Childrens Medical Center Dallas
Dallas, Texas, 75390, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Envision Clinical Research, LLC
Laredo, Texas, 78041, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Medical Clinics of Sealy
Sealy, Texas, 77474, United States
Bridgerland Clinical Research
Logan, Utah, 84341, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84132, United States
Wee Care Pediatrics
Syracuse, Utah, 84075, United States
University of Vermont Medical Center
Burlington, Vermont, 05445, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902, United States
INOVA Pediatric Digestive Diseases Center
Fairfax, Virginia, 22031, United States
The Children's Hospital of the King's Daughter
Norfolk, Virginia, 23507, United States
Pediatric Gastroenterology Carilion Medical Center
Roanoke, Virginia, 24014, United States
Northwest Clinicial Research Center
Bellevue, Washington, 98007, United States
Zain Research LLC
Richland, Washington, 99352, United States
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, 98405, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 58226, United States
Universitair Kinderziekenhuis Brussel
Brussels, 01090, Belgium
University Hospital Gasthuisberg
Leuven, 03000, Belgium
CHC - Clinique Saint-Joseph
Montegnée, 04420, Belgium
London Health Sciences Centre
London, Ontario, N6C 2V5, Canada
Centre de recherche du CHUS
Sherbrooke, Quebec, J1H 5N4, Canada
Sainte Justine University Health Center
Montreal, H3T 1C5, Canada
CHU-Bordeaux
Bordeaux, 33000, France
Groupe Hospitalier Est
Bron, 69677, France
Armand-Trousseau Teaching Hospital
Paris, 75012, France
Hôpital Necker
Paris, 75743, France
Emma Children's Hospital
Amsterdam, 1105 AZ, Netherlands
Amphia Ziekenhuis
Breda, 4800 RK, Netherlands
Maasstad Hospital Rotterdam
Rotterdam, 3079 DZ, Netherlands
Isala Klinieken
Zwolle, 8025 AB, Netherlands
Medical University of Bialystok
Bialystok, 15-274, Poland
Szpital Uniwersytecki
Bydgoszcz, 85-168, Poland
ATOPIA Poradnie Specjalistyczne
Krakow, 31-159, Poland
Medical University of Lodz
Lodz, 91-738, Poland
Szpital Pediatryczny ICZMP
Lodz, 93-338, Poland
Gabinet Lekarski Bartosc Korczowski
Rzeszów, 35-210, Poland
Children's Memorial Health Institute
Warsaw, 00-632, Poland
Przychodnia Specjalistyczna PROSEN
Warsaw, 01-231, Poland
Children's Memorial Health Institute
Warsaw, 04-730, Poland
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Darlington Memorial Hospital
Darlington, DL3 6HZ, United Kingdom
Royal Hospital for Sick Children
Glasgow, G3 8SJ, United Kingdom
Royal London Hospital
London, E1 1BB, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH, United Kingdom
Great Ormond Street Hospital for children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
Sheffield Children Hospital
Sheffield, S10 2TH, United Kingdom
Related Publications (1)
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.
PMID: 33838349DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Outcome measures were not identified as such in the protocol, and some tables were recalculated at the request of the Food and Drug Administration, so revised data necessary to calculate the primary endpoint were posted.
Results Point of Contact
- Title
- Clinical Team Leader
- Organization
- Mallinckrodt Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- While the care provider and outcomes assessor were also blinded, this was classified as a double-blind trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2014
First Posted
January 22, 2014
Study Start
December 13, 2013
Primary Completion
July 27, 2016
Study Completion
July 27, 2016
Last Updated
July 21, 2020
Results First Posted
July 21, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
Basic results are provided here, with statistical results and discussion reserved for publications.