Efficacy and Safety of Synera in Osteoarthritis Pain
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Synera in OA Pain|
- Index Knee Pain Scores on a Numeric Rating Scale (NRS) [ Time Frame: 5 minutes after stopped exercise, performed 1 hour after intervention (patch application) ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Synera
lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654302
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Thomas J Schnitzer, MD, PhD||Northwestern University|