Efficacy and Safety of Synera in Osteoarthritis Pain

Knee Osteoarthritis Clinical Trial

Official title:

Efficacy and Safety of Synera in OA Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654302
• Other study ID #: STU00061115
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 11, 2012
• Last updated: April 22, 2015
• Start date: September 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Synera
70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
• Inactive patch
placebo patch applied once for 12 hours

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Thomas J. Schnitzer	Nuvo Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index Knee Pain Scores on a Numeric Rating Scale (NRS)	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.	5 minutes after stopped exercise, performed 1 hour after intervention (patch application)	No