Efficacy and Safety of Synera in Osteoarthritis Pain
This study is not yet open for participant recruitment.
Verified April 2013 by Northwestern University
Sponsor:
Thomas J. Schnitzer
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: April 3, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Osteoarthritis
Drug Information available for:
Lidocaine hydrochloride
Tetracaine
Tetracaine hydrochloride
Lidocaine
U.S. FDA Resources
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: | June 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:
- Men and women, age 40 years and above
- Meet American College of Rheumatology criteria for knee OA
- Knee pain most days of the week for the past month
- Knee pain > 5/10 after exercise intervention
- Capable of undertaking exercise intervention
- Stable cardiovascular function
- Able to return for all clinic visits
- Able to read and understand the informed consent document
Exclusion Criteria:
- Use of a walker to ambulate or inability to ambulate
- Other forms of arthritis
- 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
- History of myocardial infarction
- Blood Pressure > 140 systolic/100 diastolic
- Scheduled for and likely to need joint replacement surgery in the next 3 months
- Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
- Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654302
Contacts
| Contact: Renita Yeasted | 312-503-2820 | renita.yeasted@northwestern.edu |
Locations
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
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: | April 3, 2013 |
| 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 May 16, 2013