Efficacy and Safety of Synera in Osteoarthritis Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01654302
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : November 10, 2014
Last Update Posted : May 12, 2015
Nuvo Research Inc.
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Synera Drug: Inactive patch Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Synera in OA Pain
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: 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 Name: placebo

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01654302

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Thomas J. Schnitzer
Nuvo Research Inc.
Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University

Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University Identifier: NCT01654302     History of Changes
Other Study ID Numbers: STU00061115
First Posted: July 31, 2012    Key Record Dates
Results First Posted: November 10, 2014
Last Update Posted: May 12, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action