Osteoarthritis, Knee Clinical Trial
Official title:
A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee
| NCT number | NCT00620867 |
| Other study ID # | A3191063 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | October 2002 |
| Est. completion date | March 2003 |
| Verified date | February 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
| Status | Completed |
| Enrollment | 393 |
| Est. completion date | March 2003 |
| Est. primary completion date | March 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | Inclusion Criteria: - Aged >= 40 years old - Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit - Functional capacity class of I-III Exclusion Criteria: - Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) - Acute joint trauma at index joint within the past 3 months with active symptoms - Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i - Use of mobility assisting device for <6 weeks or use of walker |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Altoona | Pennsylvania |
| United States | Pfizer Investigational Site | Anaheim | California |
| United States | Pfizer Investigational Site | Anniston | Alabama |
| United States | Pfizer Investigational Site | Brooklyn | New York |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Danville | Virginia |
| United States | Pfizer Investigational Site | DeLand | Florida |
| United States | Pfizer Investigational Site | Edison | New Jersey |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Greer | South Carolina |
| United States | Pfizer Investigational Site | Jenkintown | Pennsylvania |
| United States | Pfizer Investigational Site | Johnson City | Tennessee |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Layton | Utah |
| United States | Pfizer Investigational Site | Long Beach | California |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Mount Pleasant | South Carolina |
| United States | Pfizer Investigational Site | Naples | Florida |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Newtown | Pennsylvania |
| United States | Pfizer Investigational Site | Paramount | California |
| United States | Pfizer Investigational Site | Pembroke Pines | Florida |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Saint Petersburg | Florida |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | South Plainfield | New Jersey |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Warwick | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS) | Week 6 | ||
| Secondary | Vital signs | Weeks 2 and 6 | ||
| Secondary | Physical examination | Week 6 | ||
| Secondary | Laboratory test results | Week 6 | ||
| Secondary | Adverse events | Weeks 2 and 6 | ||
| Secondary | Change from baseline in patient's and physician's global assessment of pain | Weeks 2 and 6 | ||
| Secondary | Pain Satisfaction Scale | Days 1-7 | ||
| Secondary | Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index | Week 6 | ||
| Secondary | Patient Health Questionnaire (PHQ-9) | Week 6 | ||
| Secondary | Change from baseline in patient's assessment of arthritis pain according to VAS | Week 2 |
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|---|---|---|---|
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