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

NCT02807428 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2018-10-17

No results posted yet for this study

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.

Conditions

  • Post-surgical Pain

Interventions

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)

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2017-10-23
Completion
2017-12-19
FDA Drug
Yes

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 NCT02807428 on ClinicalTrials.gov