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.
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
- 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.