Efficacy and Safety of Synera in Osteoarthritis Pain

This study is currently recruiting participants.
Verified March 2014 by Northwestern University
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: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Drug: 70 mg lidocaine/ 70 mg tetracaine topical patch
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • knee pain scores on a numeric rating scale (NRS) [ Time Frame: during the 5 minutes after exercise ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Synera Drug: 70 mg lidocaine/ 70 mg tetracaine topical patch
70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
Other Name: Synera
Placebo Comparator: Inactive Patch Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654302

Contacts
Contact: Julia Marks 312-503-1215 julia.marks@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Julia Marks    312-503-1215    julia.marks@northwestern.edu   
Principal Investigator: Thomas J Schnitzer, MD, PhD         
Sponsors and Collaborators
Thomas J. Schnitzer
Nuvo Research Inc.
Investigators
Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01654302     History of Changes
Other Study ID Numbers: STU00061115
Study First Received: July 11, 2012
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014