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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2018

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At a glance

  • Drugs Lubiprostone (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Sponsors Sucampo Pharmaceuticals
  • Most Recent Events

    • 05 Jun 2018 Results presented at the Digestive Disease Week 2018
    • 30 Apr 2018 According to a Mallinckrodt plc media release, based on data from this trial, the US FDA has approved lubiprostone (AMITIZA) in children 6 to 17 years of age with paediatric functional constipation.
    • 09 Nov 2016 Primary endpoint has not been met. (Overall spontaneous bowel movement (SBM) response), according to a Sucampo Pharmaceuticals media release.
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