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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

NCT02081703 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-08-04

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 at two dose/volume levels.

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)

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
2014-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT02081703 on ClinicalTrials.gov