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A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Primary Unilateral Bunionectomy

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Primary Unilateral Bunionectomy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Cebranopadol (Primary) ; Oxycodone
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms ALLEVIATE2
  • Sponsors Assertio Therapeutics; Tris Pharma

    • Most Recent Events

    • 06 Mar 2025 According to Tris Pharma media release, company plans to submit full results from the ALLEVIATE-1 abdominoplasty and ALLEVIATE-2 bunionectomy clinical trials for presentation at an upcoming medical congress.
    • 06 Mar 2025 According to Tris Pharma media release, The ALLEVIATE-1 and ALLEVIATE-2 clinical studies, combined with strong safety data from several human abuse potential (HAP) studies, will be submitted to the U.S. Food and Drug Administration (FDA) as the basis for potential approval.
    • 06 Mar 2025 Primary endpoint (Pain NRS area under the curve: cebranopadol vs. placebo) has been met, according results presented in the Tris Pharma Media Release.

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