Efficacy and Safety of Synera in Osteoarthritis Pain

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01654302

Run by

Thomas J. Schnitzer

People needed

40

Starts

2013-09-01

Expected to finish

2015-02-01

Last updated by the study team

2015-05-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Use of a walker to ambulate or inability to ambulate
• Other forms of arthritis
• 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
• History of myocardial infarction
• Blood Pressure > 140 systolic/100 diastolic
• Scheduled for and likely to need joint replacement surgery in the next 3 months
• Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
• Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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