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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: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jan 2026

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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

  • 08 Jan 2026 Status changed from recruiting to completed.
  • 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.

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