NCT01654302

Efficacy and Safety of Synera in Osteoarthritis Pain

Efficacy and Safety of Synera in OA Pain

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Thomas J. Schnitzer · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Synera	70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
DRUG	Inactive patch	placebo patch applied once for 12 hours

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2015-02-01
• First posted: 2012-07-31
• Last updated: 2015-05-12
• Results posted: 2014-11-10

Locations

1 site across 1 country: United States