Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

Overview

A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.

Full Title of Study: “A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 4, 2016

Detailed Description

To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.

Interventions

  • Drug: Lubiprostone
    • 12 or 24 mcg soft capsules for oral administration.

Arms, Groups and Cohorts

  • Experimental: Lubiprostone
    • Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant’s weight) up to 24 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
    • Time Frame: within 25 weeks
    • Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.

Participating in This Clinical Trial

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 participant is taking antidepressants Exclusion Criteria:

  • Any gastrointestinal (GI) condition, other than constipation, 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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sucampo Pharma Americas, LLC
  • Collaborator
    • Sucampo AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Team Leader, Study Director, Mallinckrodt

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