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A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Therapy with placebo |
|
| MRX-7EAT | Experimental | Therapy with experimental drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRX-7EAT | Drug | Once daily application of a patch for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuji Kuwabara | IL Pharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35216 | United States | |||
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| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Los Angeles | California | 90036 | United States |
| San Diego | California | 92120 | United States |
| Denver | Colorado | 80239 | United States |
| Clearwater | Florida | 33761 | United States |
| Coral Gables | Florida | 33134 | United States |
| Fort Lauderdale | Florida | 33136 | United States |
| Kissimmee | Florida | 34741 | United States |
| Lauderdale Lakes | Florida | 33319 | United States |
| Miami | Florida | 33155 | United States |
| Orlando | Florida | 32804 | United States |
| Boise | Idaho | 83702 | United States |
| Lexington | Kentucky | 40504 | United States |
| Marrero | Louisiana | 70072 | United States |
| Southfield | Michigan | 48034 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Fargo | North Dakota | 58103 | United States |
| Zanesville | Ohio | 43701 | United States |
| Gresham | Oregon | 97030 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Charleston | South Carolina | 29412 | United States |
| Dallas | Texas | 75254 | United States |
| El Paso | Texas | 79902 | United States |
| San Antonio | Texas | 78207 | United States |
| San Antonio | Texas | 78229 | United States |
| Temple | Texas | 76502 | United States |
| ID | Term |
|---|---|
| D002062 | Bursitis |
| D052256 | Tendinopathy |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
| D018771 | Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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