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The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity (categorical) through 24 hours (SPI 24) | Day 2 and Day 3 | |
| Patient's Global Evaluation of Study Medication (PGESM) | Day 2 and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Intensity (derived from the mBPI-sf) on each study day | Days 2 to 5 | |
| Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day | Days 2 to 5 |
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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 | Birmingham | Alabama | 35205 | United States | ||
| 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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| valdecoxib | Drug | valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5. |
|
| valdecoxib | Drug | valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5. |
|
| Symptom Distress Scale Questionnaire | Days 2 to 5 |
| Patient Satisfaction Questionnaire for each study day | Days 2 to 5 |
| Time-specific pain intensity (PI) (categorical) on each study day | Days 2 to 5 |
| SPI 24 (Visual Analog Scale [VAS]) on each study day | Days 2 to 5 |
| Time-specific PI (VAS) on each study day | Days 2 to 5 |
| Patient's Global Evaluation of Study Medication | Day 4 and Day 5 |
| Time to first dose of rescue medication (supplemental analgesia) on each study day | Days 2 to 5 |
| Percent of subjects who took rescue medication (supplemental analgesia) on each study day | Days 2 to 5 |
| Amount of rescue medication (supplemental analgesia) taken on each study day | Days 2 to 5 |
| Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day | Days 2 to 5 |
| Time between doses of study medication on each study day | Days 2 to 5 |
| Post-Discharge Recovery Experience for each study day | Days 2 to 5 |
| SPI 24 (categorical) | Day 4 and Day 5 |
| Birmingham |
| Alabama |
| 36205 |
| United States |
| Pfizer Investigational Site | Northport | Alabama | 35476 | United States |
| Pfizer Investigational Site | Glendale | Arizona | 85310 | United States |
| Pfizer Investigational Site | Pheonix | Arizona | 85006 | United States |
| Pfizer Investigational Site | Pheonix | Arizona | 85008 | United States |
| Pfizer Investigational Site | Pheonix | Arizona | 85016 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85016 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85032 | United States |
| Pfizer Investigational Site | Tempe | Arizona | 85281 | United States |
| Pfizer Investigational Site | Glendale | California | 91206 | United States |
| Pfizer Investigational Site | Laguna Hills | California | 92653 | United States |
| Pfizer Investigational Site | Laguna Woods | California | 92653 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90045 | United States |
| Pfizer Investigational Site | Avon | Connecticut | 06001 | United States |
| Pfizer Investigational Site | Cromwell | Connecticut | 06416 | United States |
| Pfizer Investigational Site | Enfield | Connecticut | 06082 | United States |
| Pfizer Investigational Site | Farmington | Connecticut | 06030 | United States |
| Pfizer Investigational Site | Farmington | Connecticut | 06032 | United States |
| Pfizer Investigational Site | Glastonbury | Connecticut | 06033 | United States |
| Pfizer Investigational Site | Hartford | Connecticut | 06102 | United States |
| Pfizer Investigational Site | Hartford | Connecticut | 06106 | United States |
| Pfizer Investigational Site | Rocky Hill | Connecticut | 06067 | United States |
| Pfizer Investigational Site | Windsor | Connecticut | 06095 | United States |
| Pfizer Investigational Site | Hollywood | Florida | 33021 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32250 | United States |
| Pfizer Investigational Site | Plantation | Florida | 33324 | United States |
| Pfizer Investigational Site | Saint Augustine | Florida | 32086 | United States |
| Pfizer Investigational Site | St. Petersburg | Florida | 33703 | United States |
| Pfizer Investigational Site | Weston | Florida | 33326 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30327 | United States |
| Pfizer Investigational Site | Morrow | Georgia | 30260 | United States |
| Pfizer Investigational Site | Stockbridge | Georgia | 30281 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60304 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States |
| Pfizer Investigational Site | Oak Park | Illinois | 60304 | United States |
| Pfizer Investigational Site | Cedar Rapids | Iowa | 52401 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40504 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40509 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21218 | United States |
| Pfizer Investigational Site | Timonium | Maryland | 21093 | United States |
| Pfizer Investigational Site | Royal Oak | Michigan | 48073 | United States |
| Pfizer Investigational Site | Troy | Michigan | 48085 | United States |
| Pfizer Investigational Site | Springfield | Missouri | 65804 | United States |
| Pfizer Investigational Site | Springfield | Missouri | 65807 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89106 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89117 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89121 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89144 | United States |
| Pfizer Investigational Site | Bend | Oregon | 97701 | United States |
| Pfizer Investigational Site | Anderson | South Carolina | 29621 | United States |
| Pfizer Investigational Site | Cola | South Carolina | 29212 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29202 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29204 | United States |
| Pfizer Investigational Site | Orangeburg | South Carolina | 29110 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76104 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76107 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78127 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78209 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78217 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78240 | United States |
| Pfizer Investigational Site | San Marcos | Texas | 78666 | United States |
| Pfizer Investigational Site | Arlington | Virginia | 22205 | United States |
| Pfizer Investigational Site | Fairfax | Virginia | 22031 | United States |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 1T2 | Canada |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 3C8 | Canada |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 4V5 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Pfizer Investigational Site | Ajax | Ontario | L1S 2J4 | Canada |
| Pfizer Investigational Site | Ajax | Ontario | L1S 2J5 | Canada |
| Pfizer Investigational Site | Ajax | Ontario | L1S 7K8 | Canada |
| Pfizer Investigational Site | Kingston | Ontario | K7L 2V7 | Canada |
| Pfizer Investigational Site | Kingston | Ontario | K7L 5G2 | Canada |
| Pfizer Investigational Site | Scarborough Village | Ontario | M1E 4B9 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M3M 2C2 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5T 2S8 | Canada |
| Pfizer Investigational Site | Weston | Ontario | M9N 1N8 | Canada |
| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C406224 | valdecoxib |
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