NCT02807428

Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Adynxx, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty.

Detailed description

This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of AYX1 Injection administered intrathecally before surgery in patients undergoing primary unilateral total knee arthroplasty (TKA). Subjects will be randomized on the day of surgery to receive either intrathecal AYX1 Injection or intrathecal placebo just prior to surgery. Study assessments will be conducted during the inpatient period through 48 hours; follow-up visits will be performed through Study Day 90.

Conditions

• Post-surgical Pain

Interventions

Type	Name	Description
DRUG	AYX1 Injection 660 mg/6 mL	6 mL solution for intrathecal injection with 660 mg of AYX1 (Brivoligide)
DRUG	Placebo Injection 6 mL	6 mL solution for intrathecal injection; vehicle formulation designed to mimic AYX1 Injection (with no active drug)

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-10-23
• Completion: 2017-12-19
• First posted: 2016-06-21
• Last updated: 2018-10-17

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study