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A Single Arm, Open Label Study of the Safety, Efficacy, and Pharmacokinetics of SPRIX (intranasal ketorolac tromethamine) in 0 to 11 year-Old Patients Undergoing Open Surgical Procedures

Trial Profile

A Single Arm, Open Label Study of the Safety, Efficacy, and Pharmacokinetics of SPRIX (intranasal ketorolac tromethamine) in 0 to 11 year-Old Patients Undergoing Open Surgical Procedures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 May 2019

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At a glance

  • Drugs Ketorolac (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors American Regent; Egalet; Luitpold Pharmaceuticals; Zyla Life Sciences
  • Most Recent Events

    • 15 Mar 2017 Status changed from active, no longer recruiting to completed.
    • 17 Nov 2015 Planned End Date changed from 1 Sep 2015 to 1 Dec 2015 as per ClinicalTrials.gov record.
    • 07 Aug 2015 Planned End Date changed from 1 Jul 2015 to 1 Sep 2015 as per ClinicalTrials.gov record.
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