Phase 2
N=40
Efficacy and Safety of Synera in Osteoarthritis Pain
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01654302 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Index Knee Pain Scores on a Numeric Rating Scale (NRS) — 4.167; 4.703 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Synera (Drug); Inactive patch (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Thomas J. Schnitzer
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Index Knee Pain Scores on a Numeric Rating Scale (NRS) |
4.167; 4.703 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01654302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.