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| Name | Class |
|---|---|
| Nuvo Research Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synera | Active Comparator | lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper. |
|
| Inactive Patch | Placebo Comparator | placebo patch identical in appearance and composition (namely, the heating components) to the active patch other than lacking the lidocaine and tetracaine active ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synera | Drug | 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Index Knee Pain Scores on a Numeric Rating Scale (NRS) | 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. | 5 minutes after stopped exercise, performed 1 hour after intervention (patch application) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Schnitzer, MD, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Synera Then Placebo | Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7). |
| FG001 | Placebo Then Synera | Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Day 1) |
| |||||||||||||
| Second Intervention (Day 7) |
|
Baseline analysis performed for participants that completed study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Synera Then Placebo | Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7). |
| BG001 | Placebo Then Synera |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Index Knee Pain Scores on a Numeric Rating Scale (NRS) | 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. | Of the 40 subjects 2 were lost to follow-up, one from each group, making a total of 38 participants included in the analysis. Unfortunately, NRS data at 5 minutes post-exercise is missing for 2 subjects in the Synera treatment group and 1 subject in the Placebo group due to technical errors. The data was captured but we were unable to retrieve it. | Posted | Mean | Standard Deviation | units on a scale | 5 minutes after stopped exercise, performed 1 hour after intervention (patch application) |
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synera | 70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Errythmia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Marks, CRC | Northwestern University | 312-503-1215 | julia.marks@northwestern.edu |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Inactive patch | Drug | placebo patch applied once for 12 hours |
|
|
| NOT COMPLETED |
|
|
Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Index Knee Pain Scores | Subject average baseline index knee pain scores are reported prior to intervention for each group - Synera then Placebo and Placebo then Synera. 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Inactive Patch | placebo: placebo |
|
|
| 0 |
| 39 |
| 6 |
| 39 |
| EG001 | Inactive Patch | placebo: placebo | 0 | 39 | 2 | 39 |
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| D012216 |
| Rheumatic Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |