Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A3471085 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Global Evaluation of Study Medication | Day 2 and Day 3 | |
| Summed Pain Intensity (categorical) through 24 hours (SPI 24) | Day 2 and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Time-specific PI (VAS) | Days 2 to 5 | |
| Patient's Global Evaluation of Study Medication | Day 4 and Day 5 | |
| Time to first dose of rescue medication |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35213 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| valdecoxib | Drug | valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5. |
|
| valdecoxib | Drug | valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5. |
|
| Days 2 to 5 |
| Percent of patients who took rescue medication on each study day | Days 2 to 5 |
| Amount of rescue medication taken | Days 2 to 5 |
| Time between doses of study medication | Days 2 to 5 |
| Worst PI (derived from the mBPI-SF) | Days 2 to 5 |
| Average PI (derived from the mBPI-SF) | Days 2 to 5 |
| SPI 24 (categorical) | Day 4 and Day 5 |
| Time-specific PI (categorical) | Days 2 to 5 |
| SPI 24 (VAS) | Days 2 to 5 |
| Daphne |
| Alabama |
| 36526 |
| United States |
| Pfizer Investigational Site | Fairhope | Alabama | 36532 | United States |
| Pfizer Investigational Site | Mobile | Alabama | 36617 | United States |
| Pfizer Investigational Site | Mobile | Alabama | 36693 | United States |
| Pfizer Investigational Site | Sheffield | Alabama | 35660 | United States |
| Pfizer Investigational Site | Glendale | Arizona | 85306 | United States |
| Pfizer Investigational Site | Glendale | Arizona | 85308 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85006 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85020 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85023 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85027 | United States |
| Pfizer Investigational Site | Tucson | Arizona | 85710 | United States |
| Pfizer Investigational Site | Tucson | Arizona | 85711 | United States |
| Pfizer Investigational Site | Tucson | Arizona | 85712 | United States |
| Pfizer Investigational Site | Anaheim | California | 92801 | United States |
| Pfizer Investigational Site | Bakersfield | California | 93309 | United States |
| Pfizer Investigational Site | Bakersfield | California | 93311 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90017 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90057 | United States |
| Pfizer Investigational Site | Pasadena | California | 91109 | United States |
| Pfizer Investigational Site | Sacramento | California | 95817 | United States |
| Pfizer Investigational Site | San Jose | California | 95124 | United States |
| Pfizer Investigational Site | Woodland | California | 95695 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136 | United States |
| Pfizer Investigational Site | Miami | Florida | 33176 | United States |
| Pfizer Investigational Site | Pensacola | Florida | 32504 | United States |
| Pfizer Investigational Site | Blue Ridge | Georgia | 30513 | United States |
| Pfizer Investigational Site | Marietta | Georgia | 30060 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60611 | United States |
| Pfizer Investigational Site | Maywood | Illinois | 60153 | United States |
| Pfizer Investigational Site | Iowa City | Iowa | 52242 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71105 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21229 | United States |
| Pfizer Investigational Site | Germantown | Maryland | 20874 | United States |
| Pfizer Investigational Site | Rockville | Maryland | 20850 | United States |
| Pfizer Investigational Site | Silver Spring | Maryland | 20902 | United States |
| Pfizer Investigational Site | Jackson | Mississippi | 39202 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27710 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103-3315 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Pfizer Investigational Site | Allentown | Pennsylvania | 18103 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19107-4998 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29406 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29203 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29209 | United States |
| Pfizer Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Pfizer Investigational Site | North Charleston | South Carolina | 29406 | United States |
| Pfizer Investigational Site | Summerville | South Carolina | 29485 | United States |
| Pfizer Investigational Site | Bristol | Tennessee | 37620 | United States |
| Pfizer Investigational Site | Kingsport | Tennessee | 37660 | United States |
| Pfizer Investigational Site | Houston | Texas | 77024 | United States |
| Pfizer Investigational Site | Houston | Texas | 77055 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78224 | United States |
| Pfizer Investigational Site | Universal City | Texas | 78148 | United States |
| Pfizer Investigational Site | Sandy City | Utah | 84070 | United States |
| Pfizer Investigational Site | Sandy City | Utah | 84094 | United States |
| Pfizer Investigational Site | West Jordan | Utah | 84088 | United States |
| Pfizer Investigational Site | Norfolk | Virginia | 23517 | United States |
| Pfizer Investigational Site | Suffolk | Virginia | 23434 | United States |
| Pfizer Investigational Site | Renton | Washington | 98055 | United States |
| Pfizer Investigational Site | Renton | Washington | 98058-5010 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C406224 | valdecoxib |
Not provided
Not provided
Not provided