Osteoarthritis Clinical Trial
Official title:
A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicenter Study Of CE-224,535 In Subjects With Osteoarthritic Pain Of The Knee
| NCT number | NCT00418782 |
| Other study ID # | A6341008 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | January 2007 |
| Est. completion date | August 2007 |
| Verified date | December 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus placebo and naproxen treatment in patients with OA knee pain.
| Status | Terminated |
| Enrollment | 212 |
| Est. completion date | August 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Is a healthy adult 18 to 75 years of age, inclusive, in general good health and with diagnosis of knee OA, as determined by the American College of Rheumatology (ACR) clinical/radiographic classification criteria for OA of the knee. - Women must be of non childbearing potential (amenorrhea for at least 1 year PLUS have a serum follicle stimulating hormone (FSH) level >30 IU/L, bilateral oophorectomy or hysterectomy), and have a confirmed negative serum pregnancy test at the screening visit prior to randomization. Exclusion Criteria: - History of other diseases that may involve the study joint, including inflammatory joint diseases, crystalline disease, endocrinopathies, metabolic diseases, infections, neuropathic disorders, avascular necrosis, Paget's disease, or tumors. - Women of childbearing potential, or who are pregnant or lactating. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Anniston | Alabama |
| United States | Pfizer Investigational Site | Arlington | Virginia |
| United States | Pfizer Investigational Site | Ashland | Oregon |
| United States | Pfizer Investigational Site | Avon | Indiana |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Bayou La Batre | Alabama |
| United States | Pfizer Investigational Site | Beavercreek | Ohio |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Bryan | Texas |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Clearwater | Florida |
| United States | Pfizer Investigational Site | Collierville | Tennessee |
| United States | Pfizer Investigational Site | Columbia | Missouri |
| United States | Pfizer Investigational Site | DeFuniak Springs | Florida |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Destin | Florida |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Eugene | Oregon |
| United States | Pfizer Investigational Site | Flowood | Mississippi |
| United States | Pfizer Investigational Site | Frederick | Maryland |
| United States | Pfizer Investigational Site | Gretna | Louisiana |
| United States | Pfizer Investigational Site | Gurnee | Illinois |
| United States | Pfizer Investigational Site | Hot Springs | Arkansas |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kenner | Louisiana |
| United States | Pfizer Investigational Site | Kettering | Ohio |
| United States | Pfizer Investigational Site | Knoxville | Tennessee |
| United States | Pfizer Investigational Site | Longview | Texas |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Missoula | Montana |
| United States | Pfizer Investigational Site | Northridge | California |
| United States | Pfizer Investigational Site | Pensacola | Florida |
| United States | Pfizer Investigational Site | Sacramento | California |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Summerville | South Carolina |
| United States | Pfizer Investigational Site | Tarzana | California |
| United States | Pfizer Investigational Site | Trenton | New Jersey |
| United States | Pfizer Investigational Site | Westminster | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral multiple doses of CE 224,535 in subjects with OA of the knee | ongoing | ||
| Primary | The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score. | Day 1-14 | ||
| Secondary | The change from Baseline to each day (Days 1 to 6) and over the average response in Days 1 to 6 using an 11 point numeric rating scale (NRS) from 0-10 on daily pain diary; | (Days 1 to 6) | ||
| Secondary | Patient's Global Impression of Change (PGIC) at Week 2; | Week 2 | ||
| Secondary | The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition; | Baseline to Weeks 1 and 2 | ||
| Secondary | The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score; | Day 7 | ||
| Secondary | The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score; | Days 7 and 14 | ||
| Secondary | The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score; | Days 7 and 14 | ||
| Secondary | The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Total Score by simple summation; | Days 7 and 14 | ||
| Secondary | The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score; | Days 7 and 14 | ||
| Secondary | The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS) | Weeks 1 and 2 |
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