This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments 70 mg lidocaine/ 70 mg tetracaine topical patch, placebo
Phase phase 1/phase 2
Sponsor Thomas J. Schnitzer
Collaborator Nuvo Research Inc.
Start date September 2013
End date September 2014
Trial size 40 participants
Trial identifier NCT01654302, STU00061115


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
70 mg lidocaine/ 70 mg tetracaine topical patch Synera
70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
(Placebo Comparator)

Primary Outcomes

knee pain scores on a numeric rating scale (NRS)
time frame: during the 5 minutes after exercise

Secondary Outcomes

composite arthritis score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: 1 and 5 minutes, 12 hours and 1 day after exercise
Quality of life on the Short Form 12 (SF12)
time frame: 1 and 5 minutes, 12 hours and 1 day after exercise
pain quality on the Pain Quality Assessment Scale (PQAS)
time frame: 1 and 5 minutes, 12 hours and 1 day after exercise

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

Official title Efficacy and Safety of Synera in OA Pain
Principal investigator Thomas J Schnitzer, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Northwestern University.