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The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.
The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen | Active Comparator |
| |
| Synera single patch applied for 12 hrs/day | Experimental |
| |
| Synera sinlgle patch applied for 4hrs twice daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Naproxen 500mg BID for the first 2 weeks |
| |
| Synera patch twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily | Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily by the subject and the answer for question 5 is the basis for primary end poit | Day 1 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain quality assessment scale | It is a vlaidated measure to assess the qulaity of scale | Every visit from the entry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas Nalamachu, MD | International Clinical Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Clinical Research Institute | Overland Park | Kansas | 66210 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 24, 2015 | |
| Reset | Sep 23, 2015 | |
| Release | Nov 11, 2015 |
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| Drug |
1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks |
|
| Synera patch for 12hrs/day | Drug | 1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks |
|
| Naproxen | Drug | 500mg bid |
|
| Synera | Drug | Topical appication of single patch to elbow for 12hrs/day |
|
| Synera | Drug | Single patch applied to elbow for 4hrs/twice daily |
|
| Reset | Dec 14, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 24, 2015 | Sep 23, 2015 | |||
| Nov 11, 2015 | Dec 14, 2015 |
| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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