Efficacy and Safety of Synera in Osteoarthritis Pain

April 22, 2015 updated by: Thomas J. Schnitzer

Efficacy and Safety of Synera in OA Pain

Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. This study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee OA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects participated in two visits each at least 1 week apart, where they underwent two exercise interventions - a baseline exercise without treatment and a experimental exercise with intervention (Synera patch or Inactive patch). Participants rated their pain on a NRS-11 1 minute, 5 minutes, and 60 minutes after both exercises, as well as 6 hours after the experimental exercise, before bedtime, and the following morning. Subjects were randomized to receive either Synera at the first visit and the inactive patch at the second visit or the inactive patch at the first visit and Synera patch at the second visit.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women, age 40 years and above
  2. Meet American College of Rheumatology criteria for knee OA
  3. Knee pain most days of the week for the past month
  4. Knee pain > 5/10 after exercise intervention
  5. Capable of undertaking exercise intervention
  6. Stable cardiovascular function
  7. Able to return for all clinic visits
  8. Able to read and understand the informed consent document

Exclusion Criteria:

  1. Use of a walker to ambulate or inability to ambulate
  2. Other forms of arthritis
  3. Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
  4. History of myocardial infarction
  5. Blood Pressure > 140 systolic/100 diastolic
  6. Scheduled for and likely to need joint replacement surgery in the next 3 months
  7. Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
  8. Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Synera
lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.
Drug: Synera
70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
Other Names:
  • lidocaine/tetracaine
Placebo Comparator: Inactive Patch
placebo patch identical in appearance and composition (namely, the heating components) to the active patch other than lacking the lidocaine and tetracaine active ingredients.
Drug: Inactive patch
placebo patch applied once for 12 hours
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Index Knee Pain Scores on a Numeric Rating Scale (NRS)
Time Frame: 5 minutes after stopped exercise, performed 1 hour after intervention (patch application)
Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.
5 minutes after stopped exercise, performed 1 hour after intervention (patch application)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas J. Schnitzer

Collaborators

Nuvo Research Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 11, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00061115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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