NCT02081703

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

A Phase 2 Study to Evaluate the Safety & Efficacy of Two Dose/Volume Levels 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: 120 (actual)
• Sponsor: Adynxx, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 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 at two dose/volume levels.

Conditions

• Postsurgical Pain

Interventions

Type	Name	Description
DRUG	AYX1 Injection 660 mg / 6 mL	6 mL solution for intrathecal injection with 660 mg of AYX1
DRUG	AYX1 Injection 1100 mg / 10 mL	10 mL solution for intrathecal injection with 1100 mg of AYX1
DRUG	Placebo Injection 6 mL	6 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
DRUG	Placebo Injection 10 mL	10 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-03-07
• Last updated: 2015-08-04

Locations

2 sites across 1 country: United States