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Met criteria for study futility at interim analysis
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The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone | Active Comparator |
| |
| Placebo | Placebo Comparator |
| |
| PF-00592379 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the pain score averaged over the last week of treatment | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment | 2 weeks | |
| Patient Global Impression of Change | 2 weeks | |
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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 | Mobile | Alabama | 36608 | 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 |
| Drug |
Placebo: oral for 2 weeks. |
|
| PF-000592379 | Drug | PF-00592379: oral, 30 mg, once a day for 2 weeks |
|
| Patients Global Assessment of Osteoarthritis |
| 2 weeks |
| Pharmacokinetic trough levels | 2 weeks |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Pfizer Investigational Site | Carmichael | California | 95608 | United States |
| Pfizer Investigational Site | Fair Oaks | California | 95628 | United States |
| Pfizer Investigational Site | Orangevale | California | 95662 | United States |
| Pfizer Investigational Site | Roseville | California | 95661 | United States |
| Pfizer Investigational Site | Sacramento | California | 95825 | United States |
| Pfizer Investigational Site | Boca Raton | Florida | 33486 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Hollywood | Florida | 33021 | United States |
| Pfizer Investigational Site | Longwood | Florida | 32779 | United States |
| Pfizer Investigational Site | Miami | Florida | 33186 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40213 | United States |
| Pfizer Investigational Site | Madisonville | Kentucky | 42431 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63141 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Pfizer Investigational Site | New York | New York | 10022-1009 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27704 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45242 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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