A phase III trial of Validive for chemoradiation therapy induced oral mucositis

Trial Profile

A phase III trial of Validive for chemoradiation therapy induced oral mucositis

Planning
Phase of Trial: Phase III

Latest Information Update: 30 Jul 2015

At a glance

  • Drugs Clonidine (Primary)
  • Indications Stomatitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Onxeo SA
  • Most Recent Events

    • 30 Jul 2015 Planned initiation date changed from 31 Dec 2015 to 1 Jan 2016, as per Onxeo S.A. media release.
    • 26 May 2015 According to a company media release, Onxeo plans to initiate this trial by the end of 2015.
    • 22 Dec 2014 As per media release, the drug received fast track designation by the FDA in January 2014. The drug has received orphan drug status in Europe. Based on the preliminary data of phase II trial, company plans to initiate this trial in 2015.
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