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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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The purpose of the study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate wrist sprain, strain or contusion when applied to the painful area.
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion.
Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment to either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will also be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Sodium Patch | Experimental |
| |
| Placebo Patch | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Sodium Patch | Drug | Topical 1% diclofenac sodium patch, applied once daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in average pain during daily activity | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average pain during daily activity | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78704 | United States |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D013180 | Sprains and Strains |
| D003288 | Contusions |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Matching Placebo Patch | Drug | Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days |
|
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |