A Phase III, Multi-Center, Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Clinical Study to Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

Trial Profile

A Phase III, Multi-Center, Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Clinical Study to Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Aug 2017

At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Orient Pharma
  • Most Recent Events

    • 08 Aug 2017 Results published in a DURECT Corporation Media Release.
    • 08 Aug 2017 Primary endpoint has been met. (SNAP-IV teacher form score in ORADUR-Methylphenidate vs. placebo), according to a DURECT Corporation media release.
    • 10 May 2017 According to a Durect media release, dosing in this study has been completed.
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