Efficacy and Safety of Synera in Osteoarthritis Pain

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas J. Schnitzer
• Collaborator: Nuvo Research Inc.
• Treatments: Lidocaine; Tetracaine

Criteria

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.