Double-Blind, Multicenter Study Evaluating the Safety of OMS103HP and Vehicle in Subjects Undergoing Anterior Cruciate Ligament Reconstruction With an Open-Label Phase Containing a PK Analysis in a Subset of Subjects.

Trial Profile

Double-Blind, Multicenter Study Evaluating the Safety of OMS103HP and Vehicle in Subjects Undergoing Anterior Cruciate Ligament Reconstruction With an Open-Label Phase Containing a PK Analysis in a Subset of Subjects.

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2011

At a glance

  • Drugs Amitriptyline/oxymetazoline/ketoprofen (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions; Registrational
  • Most Recent Events

    • 31 Mar 2011 Primary tolerability endpoint, 'overall incidence of adverse events', was not met according to data reported in an Omeros Corporation media release.
    • 25 Mar 2011 Status changed from active, no longer recruiting to completed according to ClinicalTrials.gov.
    • 02 Feb 2010 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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