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To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 400 mg oral capsule as a single dose 1 hour prior to surgery and 200 mg oral capsule as a single dose as needed post-surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total analgesic use after surgery | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination | Day 7 | |
| Number and percentage of subjects taking analgesic (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery | 1, 2, 6, 8, 10, 12, 24, and 36 hours | |
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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 | Phoenix | Arizona | 85023 | 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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| Placebo | Other | Matched placebo |
|
| Time to analgesic use after surgery |
| 1, 2, 6, 8, 10, 12, 24, and 36 hours |
| Cumulative number of HC/APAP tablets taken after first dose of study medication | 1, 2, 6, 8, 10, 12, 36 hours and Day 2 |
| Vital signs | Day 7 |
| Patient's Assessment of Knee Pain, according to visual analogue scale at rest and with movement after surgery | 1, 2, 6, 8, 10, 12, 24 and 36 hours |
| Change in volumetric measurement of both knees from prior to surgery | Day 7 |
| Patient Treatment Satisfaction Scales after surgery | 24 hours |
| Adverse events | Day 7 |
| St. Petersburg |
| Florida |
| 33713 |
| United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21218 | United States |
| Pfizer Investigational Site | Springfield | Massachusetts | 01199 | United States |
| Pfizer Investigational Site | Springfield | Missouri | 65804 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29204 | United States |
| Pfizer Investigational Site | Johnson City | Tennessee | 37601 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Charlottesville | Virginia | 22908-0159 | United States |
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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