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Lubiprostone for Children With Constipation

Primary Purpose

Constipation - Functional

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lubiprostone
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:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • 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 Childrens Hospital Research Institute
  • WCCT Global
  • Loma Linda University Health Care
  • Children's Hospital Los Angeles
  • 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
  • Nemours Childrens Clinic
  • Children's Center for Digestive Health Care/GI Care for Kids
  • 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
  • Willis-Knighton Physician Network
  • Virgo-Carter Pediatrics
  • Gastrointestinal Associates, PA
  • University of Mississippi Medical Center
  • The Children's Mercy Hospital
  • Pioneer Clinical Research
  • Smart Medical Research, Inc.
  • NY Presbyterian Weill Cornell
  • Morgan Stanley Children's Hospital of New York Presbyterian
  • PriMed Clinical Research
  • Nationwide Children's Hospital
  • Toledo Children's Hospital
  • University of Oklahoma Health Sciences Center
  • Cyn3rgy Research
  • Square-1 Clinical Research, Inc.
  • 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.
  • 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
  • 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
  • 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
  • CHC - Clinique Saint-Joseph
  • Sainte Justine University Health Center
  • CHU-Bordeaux
  • Emma Children's Hospital
  • Amphia Ziekenhuis
  • Maasstad Hospital Rotterdam
  • Isala Klinieken
  • Medical University of Bialystok
  • Szpital Uniwersytecki
  • Szpital Pediatryczny ICZMP
  • Gabinet Lekarski Bartosc Korczowski
  • Przychodnia Specjalistyczna PROSEN
  • Children's Memorial Health Institute
  • Darlington Memorial Hospital
  • Royal London Hospital
  • Chelsea and Westminster Hospital NHS Foundation Trust
  • Sheffield Children Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lubiprostone

Arm Description

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.

Outcomes

Primary Outcome Measures

Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
Spontaneous bowel movements are defined as bowel movements without the aid of drugs.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2014
Last Updated
January 10, 2020
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02138136
Brief Title
Lubiprostone for Children With Constipation
Official Title
A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2014 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

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

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
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

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubiprostone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza®
Intervention Description
12 or 24 mcg soft capsules for oral administration
Primary Outcome Measure Information:
Title
Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
Description
Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
Time Frame
within 9 months
Other Pre-specified Outcome Measures:
Title
Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs
Description
Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse.
Time Frame
within 9 months
Title
Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs
Description
Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome.
Time Frame
within 9 months
Title
Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain
Description
Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome.
Time Frame
within 9 months

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: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
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 Childrens Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
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
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
Nemours Childrens Clinic
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Children's Center for Digestive Health Care/GI Care for Kids
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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
Willis-Knighton Physician Network
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Virgo-Carter Pediatrics
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
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
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
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
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
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
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
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
53226
Country
United States
Facility Name
Universitair Kinderziekenhuis Brussel
City
Brussel
ZIP/Postal Code
01090
Country
Belgium
Facility Name
CHC - Clinique Saint-Joseph
City
Montegnee
ZIP/Postal Code
04420
Country
Belgium
Facility Name
Sainte Justine University Health Center
City
Montreal
ZIP/Postal Code
H3T1C5
Country
Canada
Facility Name
CHU-Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
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
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
04-730
Country
Poland
Facility Name
Darlington Memorial Hospital
City
Darlington
ZIP/Postal Code
DL3 6HZ
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
Sheffield Children Hospital
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
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

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Lubiprostone for Children With Constipation

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