Phase 2 Completed N=40 Randomized Triple-blind Treatment

Efficacy and Safety of Synera in Osteoarthritis Pain

Knee Osteoarthritis

Source: ClinicalTrials.gov NCT01654302 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcomePrimary: Index Knee Pain Scores on a Numeric Rating Scale (NRS) — 4.167; 4.703 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Index Knee Pain Scores on a Numeric Rating Scale (NRS)	4.167; 4.703	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01654302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.