Lubiprostone for Children With Constipation
- Registration Number
- NCT02138136
- Lead Sponsor
- Sucampo Pharma Americas, LLC
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 419
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lubiprostone Lubiprostone Participants 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.
- Primary Outcome Measures
Name Time Method Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month within 9 months Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (85)
Gastrointestinal Associates, PA
🇺🇸Jackson, Mississippi, United States
Children's Hospital of Pittsburgh UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of South Alabama Women's and Children's Hospital
🇺🇸Mobile, Alabama, United States
Arkansas Childrens Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
Northwest Arkansas Pediatric Clinic
🇺🇸Fayetteville, Arkansas, United States
WCCT Global
🇺🇸Costa Mesa, California, United States
Loma Linda University Health Care
🇺🇸Loma Linda, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
MCB Clinical Research
🇺🇸Colorado Springs, Colorado, United States
Nemours/Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Palmetto Professional Research
🇺🇸Hialeah, Florida, United States
Savin Medical Group Research Center
🇺🇸Miami Lakes, Florida, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Nemours Childrens Clinic
🇺🇸Pensacola, Florida, United States
Children's Center for Digestive Health Care/GI Care for Kids
🇺🇸Atlanta, Georgia, United States
PediaResearch, LLC - Newburgh
🇺🇸Newburgh, Indiana, United States
Methodist Medical Center
🇺🇸Peoria, Illinois, United States
University of Iowa Children's Hospital
🇺🇸Iowa City, Iowa, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Virgo-Carter Pediatrics
🇺🇸Silver Spring, Maryland, United States
PediaResearch, LLC - Owensboro
🇺🇸Owensboro, Kentucky, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Smart Medical Research, Inc.
🇺🇸Jackson Heights, New York, United States
PriMed Clinical Research
🇺🇸Beavercreek, Ohio, United States
NY Presbyterian Weill Cornell
🇺🇸New York, New York, United States
Morgan Stanley Children's Hospital of New York Presbyterian
🇺🇸New York, New York, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Square-1 Clinical Research, Inc.
🇺🇸Erie, Pennsylvania, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
AAPRI Clinical Research
🇺🇸Warwick, Rhode Island, United States
St. Christopher's Hospital for Children Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
The Jackson Clinic, P.C.
🇺🇸Jackson, Tennessee, United States
Childrens Medical Center Dallas
🇺🇸Dallas, Texas, United States
3rd Coast Research Associates
🇺🇸Corpus Christi, Texas, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Envision Clinical Research, LLC
🇺🇸Laredo, Texas, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Bridgerland Clinical Research
🇺🇸Logan, Utah, United States
Pediatric Gastroenterology Carilion Medical Center
🇺🇸Roanoke, Virginia, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Wee Care Pediatrics
🇺🇸Syracuse, Utah, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
INOVA Pediatric Digestive Diseases Center
🇺🇸Fairfax, Virginia, United States
Northwest Clinicial Research Center
🇺🇸Bellevue, Washington, United States
Zain Research LLC
🇺🇸Richland, Washington, United States
MultiCare Health System Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States
Universitair Kinderziekenhuis Brussel
🇧🇪Brussel, Belgium
CHU-Bordeaux
🇫🇷Bordeaux, France
CHC - Clinique Saint-Joseph
🇧🇪Montegnee, Belgium
Sainte Justine University Health Center
🇨🇦Montreal, Canada
Isala Klinieken
🇳🇱Zwolle, Netherlands
Emma Children's Hospital
🇳🇱Amsterdam, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Maasstad Hospital Rotterdam
🇳🇱Rotterdam, Netherlands
Medical University of Bialystok
🇵🇱Bialystok, Poland
Szpital Uniwersytecki
🇵🇱Bydgoszcz, Poland
Szpital Pediatryczny ICZMP
🇵🇱Lodz, Poland
Gabinet Lekarski Bartosc Korczowski
🇵🇱Rzeszow, Poland
Przychodnia Specjalistyczna PROSEN
🇵🇱Warszawa, Poland
Royal London Hospital
🇬🇧London, United Kingdom
Darlington Memorial Hospital
🇬🇧Darlington, United Kingdom
Sheffield Children Hospital
🇬🇧Sheffield, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Pioneer Clinical Research
🇺🇸Bellevue, Nebraska, United States
Willis-Knighton Physician Network
🇺🇸Shreveport, Louisiana, United States
Coastal Pediatrics Associates - Mount Pleasant
🇺🇸Mount Pleasant, South Carolina, United States
Children's Memorial Health Institute
🇵🇱Warszaw, Poland
Emmerson Clinical Research
🇺🇸Washington, District of Columbia, United States
Coastal Clinical Research
🇺🇸Charleston, South Carolina, United States
University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
🇺🇸Louisville, Kentucky, United States
Coastal Pediatric Associates - James Island
🇺🇸Charleston, South Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Arizona Children's Center at Maricopa Medical Center
🇺🇸Phoenix, Arizona, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
University of Florida
🇺🇸Gainesville, Florida, United States
UnityPoint Health Des Moines/ Blank Children's Clinic
🇺🇸Des Moines, Iowa, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States