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

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Postsurgical Pain
Interventions
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)

Trial Locations (2)

Unknown

Sheffield

Phoenix

All Listed Sponsors
lead

Adynxx, Inc.

INDUSTRY

NCT02081703 - Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery | Biotech Hunter | Biotech Hunter