Lubiprostone in Children With Functional Constipation

PHASE3CompletedINTERVENTIONAL
Enrollment

606

Participants

Timeline

Start Date

December 13, 2013

Primary Completion Date

July 27, 2016

Study Completion Date

July 27, 2016

Conditions
Constipation - Functional
Interventions
DRUG

Lubiprostone

12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1

DRUG

Placebo

0 mcg soft capsules of placebo for oral administration

Trial Locations (117)

10021

NY Presbyterian Weill Cornell, New York

10032

Morgan Stanley Children's Hospital of New York Presbyterian, New York

11372

Smart Medical Research, Inc., Jackson Heights

14222

Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo, Buffalo

15224

Children's Hospital of Pittsburgh UPMC, Pittsburgh

16506

Square-1 Clinical Research, Inc., Erie

19104

Children's Hospital of Philadelphia, Philadelphia

19134

St. Christopher's Hospital for Children/Drexel University, Philadelphia

19803

Nemours/Alfred I. duPont Hospital for Children, Wilmington

20020

Emmerson Clinical Research, Washington D.C.

20910

Virgo-Carter Pediatrics, Silver Spring

21287

Johns Hopkins Children's Center, Baltimore

22031

INOVA Pediatric Digestive Diseases Center, Fairfax

22902

Pediatric Research of Charlottesville, LLC, Charlottesville

23507

The Children's Hospital of the King's Daughter, Norfolk

24014

Pediatric Gastroenterology Carilion Medical Center, Roanoke

27599

UNC School of Medicine, Chapel Hill

29303

Spartanburg Medical Research, Spartanburg

29412

Coastal Pediatric Associates - James Island, Charleston

29414

Coastal Clinical Research, Charleston

29464

Coastal Pediatrics Associates - Mount Pleasant, Mt. Pleasant

29615

Greenville Health System, Greenville

30342

Children's Center for Digestive Healthcare/GI Care for Kids, Atlanta

32207

Nemours Children's Clinic, Jacksonville

32504

Nemours Childrens Clinic, Pensacola

32610

University of Florida, Gainesville

32819

Digestive & Liver Center of Florida, Orlando

33000

CHU-Bordeaux, Bordeaux

33014

Savin Medical Group Research Center, Miami Lakes

33016

Palmetto Professional Research, Hialeah

33142

Acevedo Clinical Research Associates, Miami

35233

University of Alabama Pediatric Gastroenterology, Birmingham

36604

University of South Alabama Women's and Children's Hospital, Mobile

37232

Monroe Carell Junior Children's Hospital at Vanderbilt, Nashville

38105

Le Bonheur Children's Hospital, Memphis

38305

The Jackson Clinic, P.C., Jackson

39202

Gastrointestinal Associates, PA, Jackson

39216

University of Mississippi Medical Center, Jackson

40202

University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit, Louisville

42301

PediaResearch, LLC - Owensboro, Owensboro

43205

Nationwide Children's Hospital, Columbus

43606

Toledo Children's Hospital, Toledo

45431

PriMed Clinical Research, Beavercreek

47630

PediaResearch, LLC - Newburgh, Newburgh

50309

UnityPoint Health Des Moines/ Blank Children's Clinic, Des Moines

52242

University of Iowa Children's Hospital, Iowa City

55905

Mayo Clinic, Rochester

58226

Medical College of Wisconsin, Milwaukee

60068

Center For Children's Digestive Health, Park Ridge

61602

Methodist Medical Center, Peoria

64145

The Children's Mercy Hospital, Kansas City

67205

Heartland Research Associates, Wichita

68005

Pioneer Clinical Research, Bellevue

68504

Midwest Children's Health Research Institute, Lincoln

69677

Groupe Hospitalier Est, Bron

70118

Children's Hospital, New Orleans

71101

Willis-Knighton Physician Network, Shreveport

72202

Arkansas Children's Hospital Research Institute, Little Rock

72212

Applied Clinical Research of Arkansas, Little Rock

72703

Northwest Arkansas Pediatric Clinic, Fayetteville

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75012

Armand-Trousseau Teaching Hospital, Paris

75390

Childrens Medical Center Dallas, Dallas

75605

DCOL Center for Clinical Research, Longview

75743

Hôpital Necker, Paris

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine, Houston

77474

Medical Clinics of Sealy, Sealy

77521

A1 Clinical Research, Baytown

78041

Envision Clinical Research, LLC, Laredo

78413

3rd Coast Research Associates, Corpus Christi

78756

Austin Center for Clinical Research, Austin

79106

Texas Tech University Health Sciences Center, Amarillo

80910

MCB Clinical Research, Colorado Springs

84075

Wee Care Pediatrics, Syracuse

84132

Primary Children's Medical Center, Salt Lake City

84341

Bridgerland Clinical Research, Logan

85008

Arizona Children's Center at Maricopa Medical Center, Phoenix

85016

Phoenix Children's Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

92350

Loma Linda University Health Care, Loma Linda

92626

WCCT Global, Costa Mesa

92868

Children's Hospital of Orange County, Orange

94143

University of California, San Francisco, San Francisco

97030

Cyn3rgy Research, Gresham

98007

Northwest Clinicial Research Center, Bellevue

98405

MultiCare Health System Institute for Research and Innovation, Tacoma

99352

Zain Research LLC, Richland

02115

Boston Children's Hospital, Boston

02886

AAPRI Clinical Research, Warwick

05445

University of Vermont Medical Center, Burlington

01090

Universitair Kinderziekenhuis Brussel, Brussels

03000

University Hospital Gasthuisberg, Leuven

04420

CHC - Clinique Saint-Joseph, Montegnée

N6C 2V5

London Health Sciences Centre, London

J1H 5N4

Centre de recherche du CHUS, Sherbrooke

H3T 1C5

Sainte Justine University Health Center, Montreal

1105 AZ

Emma Children's Hospital, Amsterdam

4800 RK

Amphia Ziekenhuis, Breda

3079 DZ

Maasstad Hospital Rotterdam, Rotterdam

8025 AB

Isala Klinieken, Zwolle

15-274

Medical University of Bialystok, Bialystok

85-168

Szpital Uniwersytecki, Bydgoszcz

31-159

ATOPIA Poradnie Specjalistyczne, Krakow

91-738

Medical University of Lodz, Lodz

93-338

Szpital Pediatryczny ICZMP, Lodz

35-210

Gabinet Lekarski Bartosc Korczowski, Rzeszów

00-632

Children's Memorial Health Institute, Warsaw

01-231

Przychodnia Specjalistyczna PROSEN, Warsaw

04-730

Children's Memorial Health Institute, Warsaw

CT1 3NG

Kent and Canterbury Hospital, Canterbury

DL3 6HZ

Darlington Memorial Hospital, Darlington

G3 8SJ

Royal Hospital for Sick Children, Glasgow

E1 1BB

Royal London Hospital, London

SW10 9NH

Chelsea and Westminster Hospital NHS Foundation Trust, London

WC1N 3JH

Great Ormond Street Hospital for children NHS Foundation Trust, London

S10 2TH

Sheffield Children Hospital, Sheffield

All Listed Sponsors
collaborator

Sucampo AG

INDUSTRY

lead

Sucampo Pharma Americas, LLC

INDUSTRY

NCT02042183 - Lubiprostone in Children With Functional Constipation | Biotech Hunter | Biotech Hunter