Lubiprostone for Children With Constipation
A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
2 other identifiers
interventional
419
7 countries
85
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2014
Typical duration for phase_3
85 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
February 26, 2014
CompletedFirst Submitted
Initial submission to the registry
May 6, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
January 21, 2020
CompletedJanuary 21, 2020
January 1, 2020
3.2 years
May 6, 2014
December 13, 2019
January 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
within 9 months
Other Outcomes (3)
Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs
within 9 months
Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs
within 9 months
Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain
within 9 months
Study Arms (1)
Lubiprostone
EXPERIMENTALParticipants 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.
Interventions
12 or 24 mcg soft capsules for oral administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sucampo Pharma Americas, LLClead
- Takedacollaborator
Study Sites (85)
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 Childrens Hospital Research Institute
Little Rock, Arkansas, 72202, 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
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
Nemours Childrens Clinic
Pensacola, Florida, 32504, United States
Children's Center for Digestive Health Care/GI Care for Kids
Atlanta, Georgia, 30342, 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
Willis-Knighton Physician Network
Shreveport, Louisiana, 71101, United States
Virgo-Carter Pediatrics
Silver Spring, Maryland, 20910, 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
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
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
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
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
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
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, 53226, United States
Universitair Kinderziekenhuis Brussel
Brussels, 01090, Belgium
CHC - Clinique Saint-Joseph
Montegnée, 04420, Belgium
Sainte Justine University Health Center
Montreal, H3T1C5, Canada
CHU-Bordeaux
Bordeaux, 33000, 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
Szpital Pediatryczny ICZMP
Lodz, 93-338, Poland
Gabinet Lekarski Bartosc Korczowski
Rzeszów, 35-210, Poland
Przychodnia Specjalistyczna PROSEN
Warsaw, 01-231, Poland
Children's Memorial Health Institute
Warsaw, 04-730, Poland
Darlington Memorial Hospital
Darlington, DL3 6HZ, United Kingdom
Royal London Hospital
London, E1 1BB, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH, 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)
Results Point of Contact
- Title
- Clinical Team Leader
- Organization
- Mallinckrodt Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2014
First Posted
May 14, 2014
Study Start
February 26, 2014
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
January 21, 2020
Results First Posted
January 21, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share