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

NCT01731730 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2015-01-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Adynxx, Inc.

    lead INDUSTRY

Principal Investigators

  • Donald C Manning, MD, PhD · Adynxx, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01731730 on ClinicalTrials.gov