Clinical trial NCT02138136: Lubiprostone for Children With Constipation
Official title: A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study 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: Takeda
First posted: 2014-05-14
Enrollment: 419
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is for children with constipation.

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


Eligibility criteria: Inclusion Criteria:

* Has completed the 3-month placebo-controlled study (NCT02042183)
* Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility

Exclusion Criteria:

* Has untreated faecal impaction at the time of rolling over into study
* 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)

Primary outcomes:
measure: Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
timeFrame: within 9 months
Secondary outcomes:
Other outcomes:
measure: Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs
timeFrame: within 9 months
measure: Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs
timeFrame: within 9 months
measure: Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain
timeFrame: within 9 months
Locations:
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 Childrens Hospital Research Institute
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: 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: Pensacola
country: United States
facility: Nemours Childrens Clinic
state: Florida
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care/GI Care for Kids
state: Georgia
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: Shreveport
country: United States
facility: Willis-Knighton Physician Network
state: Louisiana
city: Silver Spring
country: United States
facility: Virgo-Carter Pediatrics
state: Maryland
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: 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: 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: 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: 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: 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: 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: Montegnee
country: Belgium
facility: CHC - Clinique Saint-Joseph
city: Montreal
country: Canada
facility: Sainte Justine University Health Center
city: Bordeaux
country: France
facility: CHU-Bordeaux
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: 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: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Children Hospital
Study officials:
affiliation: Mallinckrodt
name: Global Clinical 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.