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Completed Phase 3 Interventional Results available

Lubiprostone in Children With Functional Constipation

ClinicalTrials.gov ID: NCT02042183

Public ClinicalTrials.gov record NCT02042183. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 5:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Study identification

NCT ID
NCT02042183
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sucampo Pharma Americas, LLC
Industry
Enrollment
606 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 13, 2013 (Actual)
Primary completion
Jul 27, 2016 (Actual)
Completion
Jul 27, 2016 (Actual)
Last update posted
Jul 21, 2020

2013 – 2016

United States locations

U.S. sites
87
U.S. states
36
U.S. cities
81
Facility City State ZIP Site status
University of Alabama Pediatric Gastroenterology Birmingham Alabama 35233 —
University of South Alabama Women's and Children's Hospital Mobile Alabama 36604 —
Arizona Children's Center at Maricopa Medical Center Phoenix Arizona 85008 —
Phoenix Children's Hospital Phoenix Arizona 85016 —
Northwest Arkansas Pediatric Clinic Fayetteville Arkansas 72703 —
Arkansas Children's Hospital Research Institute Little Rock Arkansas 72202 —
Applied Clinical Research of Arkansas Little Rock Arkansas 72212 —
WCCT Global Costa Mesa California 92626 —
Loma Linda University Health Care Loma Linda California 92350 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Children's Hospital of Orange County Orange California 92868 —
University of California, San Francisco San Francisco California 94143 —
MCB Clinical Research Colorado Springs Colorado 80910 —
Nemours/Alfred I. duPont Hospital for Children Wilmington Delaware 19803 —
Emmerson Clinical Research Washington D.C. District of Columbia 20020 —
University of Florida Gainesville Florida 32610 —
Palmetto Professional Research Hialeah Florida 33016 —
Nemours Children's Clinic Jacksonville Florida 32207 —
Acevedo Clinical Research Associates Miami Florida 33142 —
Savin Medical Group Research Center Miami Lakes Florida 33014 —
Digestive & Liver Center of Florida Orlando Florida 32819 —
Nemours Childrens Clinic Pensacola Florida 32504 —
Children's Center for Digestive Healthcare/GI Care for Kids Atlanta Georgia 30342 —
Center For Children's Digestive Health Park Ridge Illinois 60068 —
Methodist Medical Center Peoria Illinois 61602 —
PediaResearch, LLC - Newburgh Newburgh Indiana 47630 —
UnityPoint Health Des Moines/ Blank Children's Clinic Des Moines Iowa 50309 —
University of Iowa Children's Hospital Iowa City Iowa 52242 —
Heartland Research Associates Wichita Kansas 67205 —
University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit Louisville Kentucky 40202 —
PediaResearch, LLC - Owensboro Owensboro Kentucky 42301 —
Children's Hospital New Orleans Louisiana 70118 —
Willis-Knighton Physician Network Shreveport Louisiana 71101 —
Johns Hopkins Children's Center Baltimore Maryland 21287 —
Virgo-Carter Pediatrics Silver Spring Maryland 20910 —
Boston Children's Hospital Boston Massachusetts 02115 —
Mayo Clinic Rochester Minnesota 55905 —
Gastrointestinal Associates, PA Jackson Mississippi 39202 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
The Children's Mercy Hospital Kansas City Missouri 64145 —
Pioneer Clinical Research Bellevue Nebraska 68005 —
Midwest Children's Health Research Institute Lincoln Nebraska 68504 —
Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo Buffalo New York 14222 —
Smart Medical Research, Inc. Jackson Heights New York 11372 —
NY Presbyterian Weill Cornell New York New York 10021 —
Morgan Stanley Children's Hospital of New York Presbyterian New York New York 10032 —
UNC School of Medicine Chapel Hill North Carolina 27599 —
PriMed Clinical Research Beavercreek Ohio 45431 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Toledo Children's Hospital Toledo Ohio 43606 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Cyn3rgy Research Gresham Oregon 97030 —
Square-1 Clinical Research, Inc. Erie Pennsylvania 16506 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
St. Christopher's Hospital for Children/Drexel University Philadelphia Pennsylvania 19134 —
Children's Hospital of Pittsburgh UPMC Pittsburgh Pennsylvania 15224 —
AAPRI Clinical Research Warwick Rhode Island 02886 —
Coastal Pediatric Associates - James Island Charleston South Carolina 29412 —
Coastal Clinical Research Charleston South Carolina 29414 —
Greenville Health System Greenville South Carolina 29615 —
Coastal Pediatrics Associates - Mount Pleasant Mt. Pleasant South Carolina 29464 —
Spartanburg Medical Research Spartanburg South Carolina 29303 —
The Jackson Clinic, P.C. Jackson Tennessee 38305 —
Le Bonheur Children's Hospital Memphis Tennessee 38105 —
Monroe Carell Junior Children's Hospital at Vanderbilt Nashville Tennessee 37232 —
Texas Tech University Health Sciences Center Amarillo Texas 79106 —
Austin Center for Clinical Research Austin Texas 78756 —
A1 Clinical Research Baytown Texas 77521 —
3rd Coast Research Associates Corpus Christi Texas 78413 —
Childrens Medical Center Dallas Dallas Texas 75390 —
Cook Children's Medical Center Fort Worth Texas 76104 —
Baylor College of Medicine Houston Texas 77030 —
Envision Clinical Research, LLC Laredo Texas 78041 —
DCOL Center for Clinical Research Longview Texas 75605 —
Medical Clinics of Sealy Sealy Texas 77474 —
Bridgerland Clinical Research Logan Utah 84341 —
Primary Children's Medical Center Salt Lake City Utah 84132 —
Wee Care Pediatrics Syracuse Utah 84075 —
University of Vermont Medical Center Burlington Vermont 05445 —
Pediatric Research of Charlottesville, LLC Charlottesville Virginia 22902 —
INOVA Pediatric Digestive Diseases Center Fairfax Virginia 22031 —
The Children's Hospital of the King's Daughter Norfolk Virginia 23507 —
Pediatric Gastroenterology Carilion Medical Center Roanoke Virginia 24014 —
Northwest Clinicial Research Center Bellevue Washington 98007 —
Zain Research LLC Richland Washington 99352 —
MultiCare Health System Institute for Research and Innovation Tacoma Washington 98405 —
Medical College of Wisconsin Milwaukee Wisconsin 58226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02042183, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 21, 2020 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02042183 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →