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

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

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

    • 09 Nov 2016 Primary endpoint has not been met. (Overall spontaneous bowel movement (SBM) response), according to a Sucampo Pharmaceuticals media release.
    • 14 Oct 2016 Status changed from active, no longer recruiting to completed.
    • 04 May 2016 According to a Sucampo media release, top-line data from this trial and a new drug application filing are expected in the second half of 2016.
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