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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: 10 Dec 2018

At a glance

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

    • 18 Sep 2018 According to a DURECT Corporation, Orient Pharma expects to have the product commercially available in Taiwan in 2019, while seeking a partner in China and pursuing regulatory approvals in selected other countries where it has commercialization rights and a commercialization presence.
    • 18 Sep 2018 According to a DURECT Corporation, based on the data from this trial, Orient Pharma has obtained marketing authorization from the Ministry of Health and Welfare in Taiwan for Methydur Sustained Release Capsules, for the treatment of attention deficit hyperactivity disorder in three strengths (22 mg, 33 mg and 44 mg) in Taiwan.
    • 31 Aug 2018 Biomarkers information updated
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