Osteoarthritis, Knee Clinical Trial
— CLOAKOfficial title:
A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-month Treatment of Subjects With Osteoarthritis of the Knee
| NCT number | NCT00643799 |
| Other study ID # | A3191152 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | March 2004 |
| Est. completion date | January 2005 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
| Status | Completed |
| Enrollment | 586 |
| Est. completion date | January 2005 |
| Est. primary completion date | January 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | Inclusion Criteria: - Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit - Functional Capacity Classification of I-III Exclusion Criteria: - Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) - Received acetaminophen within 24 hours of the baseline visit - Acute joint trauma at index joint within the past 3 months with active symptoms - History of gastrointestinal (GI) perforation, obstruction, or bleeding - Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication - Received corticosteroids or hyaluronic acid within certain timeframe before study |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Beachwood | Ohio |
| United States | Pfizer Investigational Site | Bethlehem | Pennsylvania |
| United States | Pfizer Investigational Site | Buena Park | California |
| United States | Pfizer Investigational Site | Clearwater | Florida |
| United States | Pfizer Investigational Site | Clinton | Maryland |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Covington | Louisiana |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | DeLand | Florida |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Flowood | Mississippi |
| United States | Pfizer Investigational Site | Greenbelt | Maryland |
| United States | Pfizer Investigational Site | Hagerstown | Maryland |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Lansing | Michigan |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lincoln | Nebraska |
| United States | Pfizer Investigational Site | Lincoln | Nebraska |
| United States | Pfizer Investigational Site | Media | Pennsylvania |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Milford | Massachusetts |
| United States | Pfizer Investigational Site | Montgomery | Alabama |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Orlando | Florida |
| 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 | Rancho Mirage | California |
| United States | Pfizer Investigational Site | Rockford | Illinois |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Angelo | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tempe | Arizona |
| United States | Pfizer Investigational Site | Warwick | Rhode Island |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | Wheaton | Maryland |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score | Month 6 | ||
| Secondary | Number of health care professional contacts | Throughout study | ||
| Secondary | Patient's and Physician's Satisfaction with Current Arthritis Therapy | Month 6 | ||
| Secondary | Change in WOMAC Total Score from baseline | Month 6 | ||
| Secondary | Change in WOMAC Subscales from baseline | Month 6 | ||
| Secondary | Response in each WOMAC Subscale | Month 6 | ||
| Secondary | Change in Medical Outcome Study sleep scale from baseline | Month 6 | ||
| Secondary | Laboratory tests | Month 6 | ||
| Secondary | Vital signs | Month 6 | ||
| Secondary | Response in VAS | Month 6 | ||
| Secondary | Change in Patient's and Physician's Global Assessment of Pain from baseline | Month 6 | ||
| Secondary | Change in visual analog scale (VAS) from baseline | Month 6 | ||
| Secondary | Adverse events | Throughout study | ||
| Secondary | Change in Gastrointestinal (GI) Distress Scale from Week 1 | Month 6 | ||
| Secondary | Change in GI Distress Scale from time of discontinuation of study drug | Month 6 | ||
| Secondary | Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug) | Throughout study | ||
| Secondary | Number of hospitalizations, emergency room visits, and procedures | Throughout study | ||
| Secondary | Change in Work Limitation Questionnaire scale scores from baseline | Month 6 | ||
| Secondary | Physical examination | Month 6 |
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|---|---|---|---|
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