We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-term Safety and Efficacy of Lubiprostone in Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02138136
First Posted: May 14, 2014
Last Update Posted: November 30, 2017
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.
Collaborators:
Sucampo Pharma Americas, LLC
Takeda
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo AG )
  Purpose
A study of the long-term safety and efficacy of Lubiprostone in subjects aged ≥ 6 to < 18 years diagnosed with Functional Constipation

Condition Intervention Phase
Constipation - Functional Drug: Lubiprostone Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sucampo Pharma Americas, LLC ( Sucampo AG ):

Primary Outcome Measures:
  • Evaluation of incidence of adverse events (AEs) [ Time Frame: Across 9-month treatment period ]
  • Evaluation of changes in clinical laboratory parameters [ Time Frame: Across 9-month treatment period ]
  • Evaluation of changes in physical examination [ Time Frame: Across 9-month treatment period ]
  • Evaluation of changes in vital sign measurements [ Time Frame: Across 9-month treatment period ]
  • Assessment of bone mineral density and bone mineral content [ Time Frame: Across 9-month treatment period ]

Secondary Outcome Measures:
  • Changes from baseline in bowel movement (BM) and spontaneous bowel movement (SBM) frequency rate [ Time Frame: Monthly for up to 9 months ]
  • Changes from baseline in stool consistency of SBMs. [ Time Frame: Monthly for up to 9 months ]
  • Monthly SBM Response [ Time Frame: Monthly for up to 9 months ]
  • Treatment effectiveness rating [ Time Frame: Monthly for up to 9 months ]
  • Overall Health-related quality of life (PedsQL™) [ Time Frame: Monthly for up to 9 months ]
  • Change from baseline in incontinence episodes frequency [ Time Frame: Monthly for up to 9 months ]
  • Change from baseline in the production of large diameter stool [ Time Frame: Monthly for up to 9 months ]
  • Change from baseline in frequency of faecal impaction [ Time Frame: Monthly for up to 9 months ]
  • Change from baseline in proportion of BMs and SBMs in toilet overall [ Time Frame: Monthly for up to 9 months ]
  • Change from baseline in frequency of retentive posturing or excessive volitional stool retention [ Time Frame: Monthly for up to 9 months ]
  • Changes from baseline in straining associated with SBMs. [ Time Frame: Monthly for up to 9 months ]
  • Changes from baseline in abdominal pain associated with SBMs. [ Time Frame: Monthly for up to 9 months ]
  • Changes from baseline in constipation severity. [ Time Frame: Monthly for up to 9 months ]

Enrollment: 420
Actual Study Start Date: March 2014
Study Completion Date: August 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubiprostone
Lubiprostone 12 or 24 mcg twice daily (BID)
Drug: Lubiprostone
12 or 24 mcg capsules twice daily (BID) for 9 months
Other Name: Amitiza®

Detailed Description:
The purpose of this study is to assess the long-term safety, efficacy, and pharmacokinetics of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) when administered orally for 36 weeks in paediatric subjects with functional constipation.
  Eligibility

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.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed 12 weeks of blinded treatment in the SAG/0211PFC-1131 study.
  • Continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility.

Exclusion Criteria:

  • Untreated faecal impaction at the time of rolling over into study.
  • Significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease.
  • Demonstrated non-compliance with study protocol during the SAG/0211PFC-1131 study.
  Contacts and Locations
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


  Show 85 Study Locations
Sponsors and Collaborators
Sucampo AG
Sucampo Pharma Americas, LLC
Takeda
Investigators
Principal Investigator: Carlo Di Lorenzo, MD Nationwide Children's Hospital
  More Information

Responsible Party: Sucampo AG
ClinicalTrials.gov Identifier: NCT02138136     History of Changes
Other Study ID Numbers: SAG/0211PFC-11S1
First Submitted: May 6, 2014
First Posted: May 14, 2014
Last Update Posted: November 30, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action