A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee
NCT ID: NCT00396955
Last Updated: 2007-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
560 participants
INTERVENTIONAL
2006-11-30
2007-11-30
Brief Summary
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Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers related to clinical responses. To assess PLA-695 exposure-response relationship on PD, efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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PLA-695
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with idiopathic OA of the knee for at least 3 months duration in accordance with \[1986\] American College of Rheumatology (ACR) clinical and radiographic criteria: knee pain, the presence of osteophytes, and any one of the following: age \>50 years, crepitus, or morning stiffness \<30 minutes.
* Radiographic confirmation of OA at the target joint (weight-bearing anteroposterior and lateral views) within 1 year of screening.
* Must be currently treated for OA with a stable daily dose of 1 NSAID, including COX-2 inhibitors, not exceeding the maximum recommended dose in the product label, and taken as prescribed by the physician, starting at least 4 weeks before the screening visit.
Exclusion Criteria
* Grade 4 severity on the Kellgren-Lawrence Scale on the screening target knee radiograph.
* Any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject's participating in the study or that may prevent the successful completion of the study.
* Any clinically significant laboratory abnormality.
50 Years
75 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Huntsville, Alabama, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Palo Alto, California, United States
Rancho Mirage, California, United States
Santa Maria, California, United States
Upland, California, United States
Delray Beach, Florida, United States
Fort Lauderdale, Florida, United States
Ocala, Florida, United States
Palm Harbor, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Frederick, Maryland, United States
Fall River, Massachusetts, United States
Kalamazoo, Michigan, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Dover, New Hampshire, United States
Mamaroneck, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Duncansville, Pennsylvania, United States
West Reading, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Capital Federal, Buenos Aires, Argentina
Capital Federal, Buenos Aires, Argentina
Cordoba-Capital, Córdoba Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
São Paulo, São Paulo, Brazil
Coquitlam, British Columbia, Canada
Kelowna, British Columbia, Canada
Langley, British Columbia, Canada
Penticton, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Trois-Rivières, Quebec, Canada
Hong Kong, , Hong Kong
Békéscsaba, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Kiskunhalas, , Hungary
Nyíregyháza, , Hungary
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Mexico City, , Mexico
's-Hertogenbosch, , Netherlands
Almere Stad, , Netherlands
Geleen, , Netherlands
Nijmegen, , Netherlands
Krakow, , Poland
Krakow, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
A Coruña, , Spain
Guadalajara, , Spain
Madrid, , Spain
Seville, , Spain
Countries
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Other Identifiers
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3175A1-202
Identifier Type: -
Identifier Source: org_study_id