Lubiprostone for Children With Constipation

A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

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

Study Overview

• Status: Completed
• Conditions: Constipation - Functional
• Intervention / Treatment: Drug: Lubiprostone

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 01090
    • Universitair Kinderziekenhuis Brussel
  • Montegnee, Belgium, 04420
    • CHC - Clinique Saint-Joseph
• Canada
  • Montreal, Canada, H3T1C5
    • Sainte Justine University Health Center
• France
  • Bordeaux, France, 33000
    • CHU-Bordeaux
• 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
  • Lodz, Poland, 93-338
    • Szpital Pediatryczny ICZMP
  • Rzeszow, Poland, 35-210
    • Gabinet Lekarski Bartosc Korczowski
  • Warszaw, Poland, 04-730
    • Children's Memorial Health Institute
  • Warszawa, Poland, 01-231
    • Przychodnia Specjalistyczna PROSEN
• United Kingdom
  • Darlington, United Kingdom, DL3 6HZ
    • Darlington Memorial Hospital
  • London, United Kingdom, E1 1BB
    • Royal London Hospital
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital NHS Foundation Trust
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children Hospital
• United States
  • Alabama
    • 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 Childrens Hospital Research Institute
  • 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
    • 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
    • Pensacola, Florida, United States, 32504
      • Nemours Childrens Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Center for Digestive Health Care/GI Care for Kids
  • Illinois
    • 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
    • Shreveport, Louisiana, United States, 71101
      • Willis-Knighton Physician Network
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Virgo-Carter Pediatrics
  • 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
  • New York
    • 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
  • 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, 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.
  • Texas
    • 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
  • 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
    • 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, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Lubiprostone; 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.

Drug: Lubiprostone; 12 or 24 mcg soft capsules for oral administration; Other Names: Amitiza®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month	Spontaneous bowel movements are defined as bowel movements without the aid of drugs.	within 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs	Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse.	within 9 months
Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs	Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome.	within 9 months
Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain	Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome.	within 9 months

Collaborators and Investigators

• Sponsor: Sucampo Pharma Americas, LLC
• Collaborators: Takeda

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2014
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (ESTIMATE): May 14, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: SAG-0211PFC-11S1; 2013-004384-31 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No