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Trial record 5 of 6 for:    lubiprostone, pharmacokinetics

Efficacy and Safety of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years 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. Identifier: NCT02042183
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : March 26, 2018
Sucampo Pharma Americas, LLC
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo AG )

Brief Summary:
A study of the efficacy and safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to < 18 years diagnosed with Functional Constipation

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

Detailed Description:
To assess the efficacy, safety, and pharmacokinetics (PK) of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) (based on subject body weight at baseline) as compared to matching placebo BID, when administered orally for 12 weeks in pediatric subjects with functional constipation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : December 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Lubiprostone
12 or 24 mcg capsules twice daily (BID)
Drug: Lubiprostone
12 mcg or 24 mcg administered orally twice daily (BID)
Other Name: Amitiza

Placebo Comparator: Placebo
0 mcg capsules twice daily (BID)
Drug: Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)
Other Name: No other names

Primary Outcome Measures :
  1. Overall spontaneous bowel movement (SBM) response [ Time Frame: Weeks 1-12 ]

Secondary Outcome Measures :
  1. Overall change from baseline in SBM frequency across the 12-week treatment period [ Time Frame: Weeks 1-12 ]
  2. Monthly SBM responder rates [ Time Frame: Weeks 1-12 ]
  3. Overall change from baseline in bowel movement (BM) and SBM frequency [ Time Frame: Weeks 1-12 ]
  4. Time to first SBM [ Time Frame: 0-48 hours ]
  5. Changes from baseline in straining associated with SBMs, stool consistency of SBMs, abdominal pain, constipation severity, and treatment effectiveness [ Time Frame: Weeks 1-12 ]
  6. Overall health-related quality of life [ Time Frame: Weeks 1-12 ]
  7. Treatment response [ Time Frame: Weeks 1-12 ]
  8. Change from baseline in incontinence episodes frequency [ Time Frame: Weeks 1-12 ]
  9. Change from baseline in the production of large diameter stool [ Time Frame: Weeks 1-12 ]
  10. Frequency of faecal impaction [ Time Frame: Weeks 1-12 ]
  11. Proportion of BMs and SBMs in toilet [ Time Frame: Weeks 1-12 ]
  12. Frequency of retentive posturing or excessive volitional stool retention [ Time Frame: Weeks 1-12 ]
  13. Percentage of subjects with an SBM within 4, 8, 12, 24 and 48 hours of first study medication administration [ Time Frame: 0-48 hours ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT02042183

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Sponsors and Collaborators
Sucampo AG
Sucampo Pharma Americas, LLC
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Principal Investigator: Carlo Di Lorenzo, MD Nationwide Children's Hospital

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Responsible Party: Sucampo AG Identifier: NCT02042183     History of Changes
Other Study ID Numbers: SAG/0211PFC-1131
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

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