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Efficacy and safety study of Amelior [ibuprofen] in hospitalized adult orthopedic patients.

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Trial Profile

Efficacy and safety study of Amelior [ibuprofen] in hospitalized adult orthopedic patients.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2021

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At a glance

  • Drugs Ibuprofen (Primary)
  • Indications Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Cumberland Pharmaceuticals
  • Most Recent Events

    • 29 Nov 2021 According to a Cumberland Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor, an intravenously delivered formulation of ibuprofen, to now include use in pre-operative administration. The expanded use of Caldolo was supported by data from this trial.
    • 07 Dec 2011 Additional trial location (South Africa) identified as reported by ClinicalTrials.gov.
    • 30 Aug 2010 Primary endpoint 'Pain on movement' has been met.

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