Clinical trial NCT02042183: Lubiprostone in Children With Functional Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation - Functional
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Sucampo AG
First posted: 2014-01-22
Enrollment: 606
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Classified as Overall Responders at Week 12
timeFrame: at Week 12
Secondary outcomes:
measure: Mean Number of SBMs Observed Each Week for 12 Weeks
timeFrame: within 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Pediatric Gastroenterology
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Women's and Children's Hospital
state: Alabama
city: Phoenix
country: United States
facility: Arizona Children's Center at Maricopa Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Little Rock
country: United States
facility: Applied Clinical Research of Arkansas
state: Arkansas
city: Costa Mesa
country: United States
facility: WCCT Global
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health Care
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research
state: Colorado
city: Wilmington
country: United States
facility: Nemours/Alfred I. duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Emmerson Clinical Research
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hialeah
country: United States
facility: Palmetto Professional Research
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group Research Center
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Orlando
country: United States
facility: Digestive & Liver Center of Florida
state: Florida
city: Pensacola
country: United States
facility: Nemours Childrens Clinic
state: Florida
city: Atlanta
country: United States
facility: Children's Center for Digestive Healthcare/GI Care for Kids
state: Georgia
city: Park Ridge
country: United States
facility: Center For Children's Digestive Health
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center
state: Illinois
city: Newburgh
country: United States
facility: PediaResearch, LLC - Newburgh
state: Indiana
city: Des Moines
country: United States
facility: UnityPoint Health Des Moines/ Blank Children's Clinic
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
state: Kentucky
city: Owensboro
country: United States
facility: PediaResearch, LLC - Owensboro
state: Kentucky
city: New Orleans
country: United States
facility: Children's Hospital
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
city: Silver Spring
country: United States
facility: Virgo-Carter Pediatrics
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: Bellevue
country: United States
facility: Pioneer Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Buffalo
country: United States
facility: Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo
state: New York
city: Jackson Heights
country: United States
facility: Smart Medical Research, Inc.
state: New York
city: New York
country: United States
facility: NY Presbyterian Weill Cornell
state: New York
city: New York
country: United States
facility: Morgan Stanley Children's Hospital of New York Presbyterian
state: New York
city: Chapel Hill
country: United States
facility: UNC School of Medicine
state: North Carolina
city: Beavercreek
country: United States
facility: PriMed Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Erie
country: United States
facility: Square-1 Clinical Research, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children/Drexel University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh UPMC
state: Pennsylvania
city: Warwick
country: United States
facility: AAPRI Clinical Research
state: Rhode Island
city: Charleston
country: United States
facility: Coastal Pediatric Associates - James Island
state: South Carolina
city: Charleston
country: United States
facility: Coastal Clinical Research
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Pediatrics Associates - Mount Pleasant
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic, P.C.
state: Tennessee
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Monroe Carell Junior Children's Hospital at Vanderbilt
state: Tennessee
city: Amarillo
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Baytown
country: United States
facility: A1 Clinical Research
state: Texas
city: Corpus Christi
country: United States
facility: 3rd Coast Research Associates
state: Texas
city: Dallas
country: United States
facility: Childrens Medical Center Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Laredo
country: United States
facility: Envision Clinical Research, LLC
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Sealy
country: United States
facility: Medical Clinics of Sealy
state: Texas
city: Logan
country: United States
facility: Bridgerland Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Fairfax
country: United States
facility: INOVA Pediatric Digestive Diseases Center
state: Virginia
city: Norfolk
country: United States
facility: The Children's Hospital of the King's Daughter
state: Virginia
city: Roanoke
country: United States
facility: Pediatric Gastroenterology Carilion Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinicial Research Center
state: Washington
city: Richland
country: United States
facility: Zain Research LLC
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System Institute for Research and Innovation
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Brussel
country: Belgium
facility: Universitair Kinderziekenhuis Brussel
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Montegnee
country: Belgium
facility: CHC - Clinique Saint-Joseph
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre de recherche du CHUS
state: Quebec
city: Montreal
country: Canada
facility: Sainte Justine University Health Center
city: Bordeaux
country: France
facility: CHU-Bordeaux
city: Bron
country: France
facility: Groupe Hospitalier Est
city: Paris-Cedex
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Armand-Trousseau Teaching Hospital
city: Amsterdam
country: Netherlands
facility: Emma Children's Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital Rotterdam
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Bialystok
country: Poland
facility: Medical University of Bialystok
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki
city: Krakow
country: Poland
facility: ATOPIA Poradnie Specjalistyczne
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Lodz
country: Poland
facility: Szpital Pediatryczny ICZMP
city: Rzeszow
country: Poland
facility: Gabinet Lekarski Bartosc Korczowski
city: Warszawa
country: Poland
facility: Przychodnia Specjalistyczna PROSEN
city: Warszaw
country: Poland
facility: Children's Memorial Health Institute
city: Warszaw
country: Poland
facility: Children's Memorial Health Institute
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for children NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Children Hospital
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References:
citation: 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.