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Phase 3 single safety clinical trial to assess safety risk of IV Tramadol in combination with other opioid analgesics for the management of moderate-to-moderately-severe pain in adults in a medically supervised healthcare setting

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Trial Profile

Phase 3 single safety clinical trial to assess safety risk of IV Tramadol in combination with other opioid analgesics for the management of moderate-to-moderately-severe pain in adults in a medically supervised healthcare setting

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 23 Nov 2024

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At a glance

  • Drugs Tramadol (Primary) ; Morphine
  • Indications Postoperative pain
  • Focus Adverse reactions; Registrational
  • Sponsors Avenue Therapeutics

Most Recent Events

  • 14 Nov 2024 According to an Avenue Therapeutics media release, company aims to initiate the Phase 3 safety study pending additional financing or a partnership. The Company believes that the study can be completed and submitted to the FDA within 12 months of the studys initiation.
  • 04 Jan 2024 According to an Avenue Therapeutics media release, company believes study can be completed within 12 months and submitted to the FDA to address the CRL and positive study outcome could result in the FDA approval of IV tramadol.
  • 04 Jan 2024 According to an Avenue Therapeutics media release, company today announced that it has reached final agreement with the U.S. Food and Drug Administration (FDA) on this Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint, for intravenous (IV) tramadol. The final non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.

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