Efficacy and Safety of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:6 - 17
Updated:4/17/2018
Start Date:December 2013
End Date:September 2016

Use our guide to learn which trials are right for you!

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

A study of the efficacy and safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to <
18 years diagnosed with Functional Constipation

To assess the efficacy, safety, and pharmacokinetics (PK) of oral lubiprostone 12 or 24 mcg
capsules dosed twice daily (BID) (based on subject body weight at baseline) as compared to
matching placebo BID, when administered orally for 12 weeks in pediatric subjects with
functional constipation.

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
We found this trial at
88
sites
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
?
mi
from
Longview, TX
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
?
mi
from
Orange, CA
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baytown, Texas 77521
?
mi
from
Baytown, TX
Click here to add this to my saved trials
Beavercreek, Ohio 45431
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
Bellevue, Nebraska 68005
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Bellevue, Washington 98007
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Brussel,
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Burlington, Vermont 05405
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29414
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22902
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Corpus Christi, Texas 78414
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Costa Mesa, California 92626
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Erie, Pennsylvania
?
mi
from
Erie, PA
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Gresham, Oregon 97030
?
mi
from
Gresham, OR
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jackson, Mississippi 39202
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jackson, Tennessee 38301
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Jackson Heights, New York 11372
?
mi
from
Jackson Heights, NY
Click here to add this to my saved trials
Laredo, Texas 78041
?
mi
from
Laredo, TX
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Little Rock, Arkansas 72212
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Logan, Utah 84341
?
mi
from
Logan, UT
Click here to add this to my saved trials
Loma Linda, California 92350
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Memphis, Tennessee 38103
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
1952 Long Grove Drive
Mount Pleasant, South Carolina 29464
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70118
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newburgh, Indiana 47630
?
mi
from
Newburgh, IN
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32819
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Owensboro, Kentucky 42301
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Park Ridge, Illinois 60068
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Peoria, Illinois 61602
?
mi
from
Peoria, IL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Richland, Washington 99352
?
mi
from
Richland, WA
Click here to add this to my saved trials
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Sealy, Texas 77474
?
mi
from
Sealy, TX
Click here to add this to my saved trials
Shreveport, Louisiana 71118
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Silver Spring, Maryland 20910
?
mi
from
Silver Spring, MD
Click here to add this to my saved trials
Syracuse, Utah 84075
?
mi
from
Syracuse, UT
Click here to add this to my saved trials
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Toledo, Ohio 43606
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Warwick, Rhode Island 02886
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Washington, District of Columbia 20020
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wilmington, DE
Click here to add this to my saved trials