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Lubiprostone in Children With Functional Constipation

Primary Purpose

Constipation - Functional

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lubiprostone
Placebo
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Pediatric Gastroenterology
  • University of South Alabama Women's and Children's Hospital
  • Arizona Children's Center at Maricopa Medical Center
  • Phoenix Children's Hospital
  • Northwest Arkansas Pediatric Clinic
  • Arkansas Children's Hospital Research Institute
  • Applied Clinical Research of Arkansas
  • WCCT Global
  • Loma Linda University Health Care
  • Children's Hospital Los Angeles
  • Children's Hospital of Orange County
  • University of California, San Francisco
  • MCB Clinical Research
  • Nemours/Alfred I. duPont Hospital for Children
  • Emmerson Clinical Research
  • University of Florida
  • Palmetto Professional Research
  • Nemours Children's Clinic
  • Savin Medical Group Research Center
  • Acevedo Clinical Research Associates
  • Digestive & Liver Center of Florida
  • Nemours Childrens Clinic
  • Children's Center for Digestive Healthcare/GI Care for Kids
  • Center For Children's Digestive Health
  • Methodist Medical Center
  • PediaResearch, LLC - Newburgh
  • UnityPoint Health Des Moines/ Blank Children's Clinic
  • University of Iowa Children's Hospital
  • Heartland Research Associates
  • University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
  • PediaResearch, LLC - Owensboro
  • Children's Hospital
  • Willis-Knighton Physician Network
  • Johns Hopkins Children's Center
  • Virgo-Carter Pediatrics
  • Boston Children's Hospital
  • Mayo Clinic
  • Gastrointestinal Associates, PA
  • University of Mississippi Medical Center
  • The Children's Mercy Hospital
  • Pioneer Clinical Research
  • Midwest Children's Health Research Institute
  • Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo
  • Smart Medical Research, Inc.
  • NY Presbyterian Weill Cornell
  • Morgan Stanley Children's Hospital of New York Presbyterian
  • UNC School of Medicine
  • PriMed Clinical Research
  • Nationwide Children's Hospital
  • Toledo Children's Hospital
  • University of Oklahoma Health Sciences Center
  • Cyn3rgy Research
  • Square-1 Clinical Research, Inc.
  • Children's Hospital of Philadelphia
  • St. Christopher's Hospital for Children/Drexel University
  • Children's Hospital of Pittsburgh UPMC
  • AAPRI Clinical Research
  • Coastal Pediatric Associates - James Island
  • Coastal Clinical Research
  • Greenville Health System
  • Coastal Pediatrics Associates - Mount Pleasant
  • Spartanburg Medical Research
  • The Jackson Clinic, P.C.
  • Le Bonheur Children's Hospital
  • Monroe Carell Junior Children's Hospital at Vanderbilt
  • Texas Tech University Health Sciences Center
  • Austin Center for Clinical Research
  • A1 Clinical Research
  • 3rd Coast Research Associates
  • Childrens Medical Center Dallas
  • Cook Children's Medical Center
  • Baylor College of Medicine
  • Envision Clinical Research, LLC
  • DCOL Center for Clinical Research
  • Medical Clinics of Sealy
  • Bridgerland Clinical Research
  • Primary Children's Medical Center
  • Wee Care Pediatrics
  • University of Vermont Medical Center
  • Pediatric Research of Charlottesville, LLC
  • INOVA Pediatric Digestive Diseases Center
  • The Children's Hospital of the King's Daughter
  • Pediatric Gastroenterology Carilion Medical Center
  • Northwest Clinicial Research Center
  • Zain Research LLC
  • MultiCare Health System Institute for Research and Innovation
  • Medical College of Wisconsin
  • Universitair Kinderziekenhuis Brussel
  • University Hospital Gasthuisberg
  • CHC - Clinique Saint-Joseph
  • London Health Sciences Centre
  • Centre de recherche du CHUS
  • Sainte Justine University Health Center
  • CHU-Bordeaux
  • Groupe Hospitalier Est
  • Hôpital Necker
  • Armand-Trousseau Teaching Hospital
  • Emma Children's Hospital
  • Amphia Ziekenhuis
  • Maasstad Hospital Rotterdam
  • Isala Klinieken
  • Medical University of Bialystok
  • Szpital Uniwersytecki
  • ATOPIA Poradnie Specjalistyczne
  • Medical University of Lodz
  • Szpital Pediatryczny ICZMP
  • Gabinet Lekarski Bartosc Korczowski
  • Przychodnia Specjalistyczna PROSEN
  • Children's Memorial Health Institute
  • Children's Memorial Health Institute
  • Kent and Canterbury Hospital
  • Darlington Memorial Hospital
  • Royal Hospital for Sick Children
  • Royal London Hospital
  • Chelsea and Westminster Hospital NHS Foundation Trust
  • Great Ormond Street Hospital for children NHS Foundation Trust
  • Sheffield Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lubiprostone

Placebo

Arm Description

Participants receive lubiprostone twice daily (BID) up to 12 weeks

Participants receive placebo BID up to 12 weeks

Outcomes

Primary Outcome Measures

Number of Participants Classified as Overall Responders at Week 12
An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.

Secondary Outcome Measures

Mean Number of SBMs Observed Each Week for 12 Weeks
Data provided is based on observed cases. Baseline is the average of the 2 weeks before being randomized. Participants are summarized by actual dose received after week 1.

Full Information

First Posted
January 17, 2014
Last Updated
July 20, 2020
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo AG
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1. Study Identification

Unique Protocol Identification Number
NCT02042183
Brief Title
Lubiprostone in Children With Functional Constipation
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2013 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
July 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
Detailed Description
Dose administration details: Participants with a body weight <50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID. Participants with a body weight >50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Placebo controlled
Masking
ParticipantInvestigator
Masking Description
While the care provider and outcomes assessor were also blinded, this was classified as a double-blind trial
Allocation
Randomized
Enrollment
606 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubiprostone
Arm Type
Experimental
Arm Description
Participants receive lubiprostone twice daily (BID) up to 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo BID up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza
Intervention Description
12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
0 mcg soft capsules of placebo for oral administration
Primary Outcome Measure Information:
Title
Number of Participants Classified as Overall Responders at Week 12
Description
An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.
Time Frame
at Week 12
Secondary Outcome Measure Information:
Title
Mean Number of SBMs Observed Each Week for 12 Weeks
Description
Data provided is based on observed cases. Baseline is the average of the 2 weeks before being randomized. Participants are summarized by actual dose received after week 1.
Time Frame
within 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Pediatric Gastroenterology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of South Alabama Women's and Children's Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Arizona Children's Center at Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Northwest Arkansas Pediatric Clinic
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Applied Clinical Research of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
WCCT Global
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Loma Linda University Health Care
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
MCB Clinical Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Nemours/Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Emmerson Clinical Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20020
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Palmetto Professional Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Savin Medical Group Research Center
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Digestive & Liver Center of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Nemours Childrens Clinic
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Children's Center for Digestive Healthcare/GI Care for Kids
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Center For Children's Digestive Health
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Methodist Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
PediaResearch, LLC - Newburgh
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
UnityPoint Health Des Moines/ Blank Children's Clinic
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa Children's Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
PediaResearch, LLC - Owensboro
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Children's Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Willis-Knighton Physician Network
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Johns Hopkins Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Virgo-Carter Pediatrics
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Gastrointestinal Associates, PA
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64145
Country
United States
Facility Name
Pioneer Clinical Research
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Midwest Children's Health Research Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
Country
United States
Facility Name
Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Smart Medical Research, Inc.
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372
Country
United States
Facility Name
NY Presbyterian Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Morgan Stanley Children's Hospital of New York Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UNC School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
PriMed Clinical Research
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Square-1 Clinical Research, Inc.
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Christopher's Hospital for Children/Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Children's Hospital of Pittsburgh UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
AAPRI Clinical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Coastal Pediatric Associates - James Island
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Coastal Clinical Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Coastal Pediatrics Associates - Mount Pleasant
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
The Jackson Clinic, P.C.
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Monroe Carell Junior Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Austin Center for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
A1 Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
3rd Coast Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
Childrens Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Envision Clinical Research, LLC
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Medical Clinics of Sealy
City
Sealy
State/Province
Texas
ZIP/Postal Code
77474
Country
United States
Facility Name
Bridgerland Clinical Research
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Wee Care Pediatrics
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05445
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
INOVA Pediatric Digestive Diseases Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
The Children's Hospital of the King's Daughter
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Pediatric Gastroenterology Carilion Medical Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Northwest Clinicial Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Zain Research LLC
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
MultiCare Health System Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
58226
Country
United States
Facility Name
Universitair Kinderziekenhuis Brussel
City
Brussel
ZIP/Postal Code
01090
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Facility Name
CHC - Clinique Saint-Joseph
City
Montegnee
ZIP/Postal Code
04420
Country
Belgium
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2V5
Country
Canada
Facility Name
Centre de recherche du CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Sainte Justine University Health Center
City
Montreal
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
CHU-Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Groupe Hospitalier Est
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Necker
City
Paris-Cedex
ZIP/Postal Code
75743
Country
France
Facility Name
Armand-Trousseau Teaching Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Emma Children's Hospital
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4800 RK
Country
Netherlands
Facility Name
Maasstad Hospital Rotterdam
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Medical University of Bialystok
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Facility Name
Szpital Uniwersytecki
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
ATOPIA Poradnie Specjalistyczne
City
Krakow
ZIP/Postal Code
31-159
Country
Poland
Facility Name
Medical University of Lodz
City
Lodz
ZIP/Postal Code
91-738
Country
Poland
Facility Name
Szpital Pediatryczny ICZMP
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Gabinet Lekarski Bartosc Korczowski
City
Rzeszow
ZIP/Postal Code
35-210
Country
Poland
Facility Name
Przychodnia Specjalistyczna PROSEN
City
Warszawa
ZIP/Postal Code
01-231
Country
Poland
Facility Name
Children's Memorial Health Institute
City
Warszaw
ZIP/Postal Code
00-632
Country
Poland
Facility Name
Children's Memorial Health Institute
City
Warszaw
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Kent and Canterbury Hospital
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Darlington Memorial Hospital
City
Darlington
ZIP/Postal Code
DL3 6HZ
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for children NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Sheffield Children Hospital
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Basic results are provided here, with statistical results and discussion reserved for publications.
Citations:
PubMed Identifier
33838349
Citation
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.
Results Reference
derived

Learn more about this trial

Lubiprostone in Children With Functional Constipation

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