Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of Synera in Osteoarthritis Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Nuvo Research Inc.
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01654302
First received: July 11, 2012
Last updated: November 3, 2014
Last verified: November 2014

July 11, 2012
November 3, 2014
September 2013
September 2014   (final data collection date for primary outcome measure)
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.
knee pain scores on a numeric rating scale (NRS) [ Time Frame: during the 5 minutes after exercise ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01654302 on ClinicalTrials.gov Archive Site
Not Provided
  • composite arthritis score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 1 and 5 minutes, 12 hours and 1 day after exercise ] [ Designated as safety issue: No ]
  • Quality of life on the Short Form 12 (SF12) [ Time Frame: 1 and 5 minutes, 12 hours and 1 day after exercise ] [ Designated as safety issue: No ]
  • pain quality on the Pain Quality Assessment Scale (PQAS) [ Time Frame: 1 and 5 minutes, 12 hours and 1 day after exercise ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Synera in Osteoarthritis Pain
Efficacy and Safety of Synera in OA 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Drug: Synera
    70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
    Other Name: lidocaine/tetracaine
  • Drug: Inactive patch
    placebo patch applied once for 12 hours
    Other Name: placebo
  • Active Comparator: Synera
    lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.
    Intervention: Drug: Synera
  • 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.
    Intervention: Drug: Inactive patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01654302
STU00061115
No
Thomas J. Schnitzer, Northwestern University
Thomas J. Schnitzer
Nuvo Research Inc.
Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University
Northwestern University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP