Lubiprostone in Children With Functional Constipation

July 20, 2020 updated by: Sucampo Pharma Americas, LLC

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 to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
606

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lubiprostone
Participants receive lubiprostone twice daily (BID) up to 12 weeks
Drug: Lubiprostone
12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
Other Names:
  • Amitiza
Placebo Comparator: Placebo
Participants receive placebo BID up to 12 weeks
Drug: Placebo
0 mcg soft capsules of placebo for oral administration
Other Names:
  • Matching Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Classified as Overall Responders at Week 12
Time Frame: 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.
at Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Number of SBMs Observed Each Week for 12 Weeks
Time Frame: within 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.
within 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sucampo Pharma Americas, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sucampo AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAG/0211PFC-1131
  • 2013-004384-31 (EUDRACT_NUMBER)
  • EMEA-000245-PIP01-08 (Other Identifier: EMEA Paediatric Investigational Plan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Basic results are provided here, with statistical results and discussion reserved for publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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