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Lubiprostone for Children With 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: NCT02138136
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Mallinckrodt ( Sucampo Pharma Americas, LLC )

Study Description
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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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 26, 2014
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

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

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 Name: Amitiza®


Outcome Measures
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Primary Outcome Measures :
  1. Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month [ Time Frame: within 9 months ]
    Spontaneous bowel movements are defined as bowel movements without the aid of drugs.


Other Outcome Measures:
  1. Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs [ Time Frame: within 9 months ]
    Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse.

  2. Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs [ Time Frame: within 9 months ]
    Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome.

  3. Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain [ Time Frame: within 9 months ]
    Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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)
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): NCT02138136


Locations
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Sponsors and Collaborators
Sucampo Pharma Americas, LLC
Takeda
Investigators
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Study Director: Global Clinical Leader Mallinckrodt
  Study Documents (Full-Text)

Documents provided by Mallinckrodt ( Sucampo Pharma Americas, LLC ):
Study Protocol and Statistical Analysis Plan  [PDF] November 23, 2015

More Information
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Responsible Party: Sucampo Pharma Americas, LLC
ClinicalTrials.gov Identifier: NCT02138136    
Other Study ID Numbers: SAG-0211PFC-11S1
2013-004384-31 ( EudraCT Number )
First Posted: May 14, 2014    Key Record Dates
Results First Posted: January 21, 2020
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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