Efficacy and Safety of Synera in Osteoarthritis Pain
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|ClinicalTrials.gov Identifier: NCT01654302|
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : November 10, 2014
Last Update Posted : May 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Drug: Synera Drug: Inactive patch||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Synera in OA Pain|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||February 2015|
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
- Index Knee Pain Scores on a Numeric Rating Scale (NRS) [ Time Frame: 5 minutes after stopped exercise, performed 1 hour after intervention (patch application) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654302
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Thomas J Schnitzer, MD, PhD||Northwestern University|