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Lubiprostone in Children With Functional Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02042183
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : July 21, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Sucampo AG
Information provided by (Responsible Party):
Mallinckrodt ( Sucampo Pharma Americas, LLC )

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

Condition or disease Intervention/treatment Phase
Constipation - Functional Drug: Lubiprostone Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo controlled
Masking: Double (Participant, Investigator)
Masking Description: While the care provider and outcomes assessor were also blinded, this was classified as a double-blind trial
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2013
Actual Primary Completion Date : July 27, 2016
Actual Study Completion Date : July 27, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
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 Name: Amitiza
Placebo Comparator: Placebo
Participants receive placebo BID up to 12 weeks
 Drug: Placebo
0 mcg soft capsules of placebo for oral administration
Other Name: Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042183


Locations
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Sponsors and Collaborators
Sucampo Pharma Americas, LLC
Sucampo AG
Investigators
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Study Director: Clinical Team Leader Mallinckrodt
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sucampo Pharma Americas, LLC
ClinicalTrials.gov Identifier: NCT02042183    
Other Study ID Numbers: SAG/0211PFC-1131
2013-004384-31 ( EudraCT Number )
EMEA-000245-PIP01-08 ( Other Identifier: EMEA Paediatric Investigational Plan )
First Posted: January 22, 2014    Key Record Dates
Results First Posted: July 21, 2020
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Basic results are provided here, with statistical results and discussion reserved for publications.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Lubiprostone
 Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action