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| ID | Type | Description | Link |
|---|---|---|---|
| A3471037 |
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To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valdecoxib | Drug | valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient's assessment of ankle pain VAS | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of pain relief | 0, 15, 30, 45, and 60 minutes after first dose | |
| Physician's global assessment of ankle injury | Days 1, 4, and 7 | |
| Patient's global assessment of ankle injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Avellaneda | Buenos Aires | 1872 | Argentina | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| diclofenac | Drug | diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days |
|
| Days 1, 4 and 7 |
| Patient's assessment of normal function/activity | Days 1 to 7 |
| Patient's and physician's satisfaction assessments | Day 7 |
| Patient's assessment of ankle pain on visual analogue scale (VAS) | Days 1 to 7 |
| San Isidro |
| Buenos Aires |
| 1642 |
| Argentina |
| Pfizer Investigational Site | Buenos Aires | Argentina |
| Pfizer Investigational Site | Santiago | RM | Chile |
| Pfizer Investigational Site | Santiago | Chile |
| Pfizer Investigational Site | Medellín | Antioquia | (574) 5141516 | Colombia |
| Pfizer Investigational Site | Bogota | Cundinamarca | (57) 310-2322198 | Colombia |
| Pfizer Investigational Site | Bogota | Cundinamarca | (57) 310-8849622 | Colombia |
| Pfizer Investigational Site | Bogotá | Cundinarmarca | (571) 6 164278 | Colombia |
| Pfizer Investigational Site | Bucaramanga | Santander Department | (577) 6 395409 | Colombia |
| Pfizer Investigational Site | Cali | Valle del Cauca Department | (57) 315-5410469 | Colombia |
| Pfizer Investigational Site | Calli | Valle del Cauca Department | (57) 310-8259712 | Colombia |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Pfizer Investigational Site | Lima | Lima Province | 27 | Peru |
| Pfizer Investigational Site | Lima | Lima Province | Peru |
| ID | Term |
|---|---|
| D010146 | Pain |
| D013180 | Sprains and Strains |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C406224 | valdecoxib |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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