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
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History