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To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
| |
| C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 200 mg oral capsule once daily for 6 months |
| |
| Naproxen |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of health care professional contacts | Throughout study | |
| Patient's and Physician's Satisfaction with Current Arthritis Therapy | Month 6 | |
| Change in WOMAC Total Score from baseline |
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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 | Montgomery | Alabama | 36106 | 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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| Drug |
500 mg oral capsule twice daily for 6 months |
|
| Placebo | Drug | Matched oral placebo for 6 months |
|
| Month 6 |
| Change in WOMAC Subscales from baseline | Month 6 |
| Response in each WOMAC Subscale | Month 6 |
| Change in Medical Outcome Study sleep scale from baseline | Month 6 |
| Laboratory tests | Month 6 |
| Vital signs | Month 6 |
| Response in VAS | Month 6 |
| Change in Patient's and Physician's Global Assessment of Pain from baseline | Month 6 |
| Change in visual analog scale (VAS) from baseline | Month 6 |
| Adverse events | Throughout study |
| Change in Gastrointestinal (GI) Distress Scale from Week 1 | Month 6 |
| Change in GI Distress Scale from time of discontinuation of study drug | Month 6 |
| Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug) | Throughout study |
| Number of hospitalizations, emergency room visits, and procedures | Throughout study |
| Change in Work Limitation Questionnaire scale scores from baseline | Month 6 |
| Physical examination | Month 6 |
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Pfizer Investigational Site | Tempe | Arizona | 85282 | United States |
| Pfizer Investigational Site | Buena Park | California | 90620 | United States |
| Pfizer Investigational Site | Paramount | California | 90723 | United States |
| Pfizer Investigational Site | Rancho Mirage | California | 92270 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80230 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20006 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33761 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32204 | United States |
| Pfizer Investigational Site | Miami | Florida | 33186 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34474 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32804 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33614 | United States |
| Pfizer Investigational Site | Zephyrhills | Florida | 33542 | United States |
| Pfizer Investigational Site | Rockford | Illinois | 61103 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67212 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40503 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40515 | United States |
| Pfizer Investigational Site | Covington | Louisiana | 70433 | United States |
| Pfizer Investigational Site | Metairie | Louisiana | 70006 | United States |
| Pfizer Investigational Site | Clinton | Maryland | 20735 | United States |
| Pfizer Investigational Site | Greenbelt | Maryland | 20770 | United States |
| Pfizer Investigational Site | Hagerstown | Maryland | 21740 | United States |
| Pfizer Investigational Site | Wheaton | Maryland | 20902 | United States |
| Pfizer Investigational Site | Milford | Massachusetts | 01757 | United States |
| Pfizer Investigational Site | Lansing | Michigan | 48910 | United States |
| Pfizer Investigational Site | Flowood | Mississippi | 39232 | United States |
| Pfizer Investigational Site | Kansas City | Missouri | 64114 | United States |
| Pfizer Investigational Site | Lincoln | Nebraska | 68506 | United States |
| Pfizer Investigational Site | Lincoln | Nebraska | 68516 | United States |
| Pfizer Investigational Site | New York | New York | 10022 | United States |
| Pfizer Investigational Site | Beachwood | Ohio | 44122 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43124 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43215 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43222 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Pfizer Investigational Site | Bethlehem | Pennsylvania | 18015 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Pfizer Investigational Site | Media | Pennsylvania | 19603 | United States |
| Pfizer Investigational Site | Warwick | Rhode Island | 02886 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75235 | United States |
| Pfizer Investigational Site | San Angelo | Texas | 76904 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84109 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84121 | United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D009288 | Naproxen |
| 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 |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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