Efficacy and Safety of Synera in Osteoarthritis Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Synera

lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.

Group Type ACTIVE_COMPARATOR

Synera

Intervention Type DRUG

70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours

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.

Group Type PLACEBO_COMPARATOR

Inactive patch

Intervention Type DRUG

placebo patch applied once for 12 hours

Interventions

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Synera

70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours

Intervention Type DRUG

Inactive patch

placebo patch applied once for 12 hours

Intervention Type DRUG

Other Intervention Names

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lidocaine/tetracaine placebo

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No