NCT01731730

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

Study to Evaluate the Safety & Efficacy of a Single Intrathecal Pre-Operative Administration of AYX1 Injection at Two Dose Levels Compared to Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty (TKA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Adynxx, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Postsurgical Pain

Interventions

Type	Name	Description
DRUG	Placebo Injection	3mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
DRUG	AYX1 Injection 110 mg	3mL solution for intrathecal injection with 110 mg of AYX1
DRUG	AYX1 Injection 330 mg	3mL solution for intrathecal injection with 330 mg of AYX1

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2012-11-22
• Last updated: 2015-01-27

Locations

7 sites across 1 country: United States