A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of AYX1 Injection in Patients Undergoing Unilateral Total Knee Arthroplasty

Trial Profile

A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of AYX1 Injection in Patients Undergoing Unilateral Total Knee Arthroplasty

Completed
Phase of Trial: Phase II

Latest Information Update: 12 Apr 2018

At a glance

  • Drugs Brivoligide (Primary)
  • Indications Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Adynxx
  • Most Recent Events

    • 12 Apr 2018 According to an Adynxx media release, Joseph Gimbel, M.D. (orthopedic surgeon, Chief Medical Director of Arizona Research Center in Phoenix, AZ) is the principal investigator of this study.
    • 12 Apr 2018 According to results presented in an Adynxx media release, in pre-specified analyses by PCS (Pain Catastrophizing Scale) score, brivoligide showed a sustained and clinically meaningful reduction in pain and opioid use in subjects with higher PCS scores.Based on these results, the company plans to initiate a phase 3 clinical trial of brivoligide in subjects with high PCS scores.
    • 12 Apr 2018 Primary endpoint (Mean pain with walking during the 15 meter walk test Day 7 to Day 28) has not been met, according to results presented in an Adynxx media release.
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