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A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy

Trial Profile

A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Aug 2021

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At a glance

  • Drugs Vocacapsaicin (Primary)
  • Indications Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Concentric Analgesics
  • Most Recent Events

    • 26 Jan 2021 According to a Concentric Analgesics media release, an end of phase 2 Meeting with the FDA is scheduled in April 2021. Based on the available results from this and NCT04203537 and discussions with the FDA, the company will evaluate additional surgical models while finalizing plans for Phase 3.
    • 08 Nov 2018 According to a Concentric Analgesics media release, the company expects to present complete data (including pharmacokinetics and full 28-day follow-up results) from this trial at upcoming scientific meetings in 2019.
    • 08 Nov 2018 Primary endpoint (Change in Post-surgical pain based on the weighted sum of pain intensity (SPI) assessments over 96 hours of the NRS scores = Area Under the Curve (AUC): highest dose of CA-008 (4.2 mg) versus placebo) has been met, according to a Concentric Analgesics media release.
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