A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

NCT00396955 | Terminated Phase 2

• 1 other identifier: 3175A1-202
• Study Type: interventional
• Target: 560
• Locations: 10 countries
• Sites: 83

Brief Summary

Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee. 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.

Conditions

Osteoarthritis

Keywords

osteoarthritis; arthritis; pain

Outcome Measures

Primary Outcomes (1)

• WOMAC VAS walking pain (question 1) at week 6 is the primary endpoint.

Secondary Outcomes (1)

• WOMAC VAS walking pain at weeks 1, 2, 3, 4, and 5; WOMAC pain, stiffness, and function subscales, and composite score; Investigatorsâ Efficacy Evaluation; Investigatorsâ overall assessment; Joint tenderness. Subjectsâ Efficacy Evaluation.

Interventions

PLA-695 DRUG

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 50 to 75 years of age. Women must be of non-childbearing potential. Sexually active men who are not surgically sterile must agree and commit to use of barrier contraception during the study and for at least 12 weeks after the last dose of PLA.
• 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.

You may not qualify if:

• History of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis.
• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (83)

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Huntsville, Alabama, 35801, United States

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, United States

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Palo Alto, California, 94304, United States

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Rancho Mirage, California, 92270, United States

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Santa Maria, California, 93455, United States

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Upland, California, 91786, United States

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Delray Beach, Florida, 33484, United States

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Fort Lauderdale, Florida, 33334, United States

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Ocala, Florida, 34474, United States

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Palm Harbor, Florida, 34684, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33614, United States

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Idaho Falls, Idaho, 83401, United States

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Chicago, Illinois, 60611, United States

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Wichita, Kansas, 67208, United States

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Baltimore, Maryland, 21224, United States

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Frederick, Maryland, 21702, United States

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Fall River, Massachusetts, 02720, United States

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Kalamazoo, Michigan, 49048, United States

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St Louis, Missouri, 63128, United States

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Las Vegas, Nevada, United States

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Dover, New Hampshire, 03820, United States

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Mamaroneck, New York, 10543, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28210, United States

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Duncansville, Pennsylvania, 16635, United States

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West Reading, Pennsylvania, 19611, United States

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Willow Grove, Pennsylvania, 19090, United States

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Charleston, South Carolina, 29406, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75235, United States

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San Antonio, Texas, 78217, United States

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Salt Lake City, Utah, 84107, United States

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Seattle, Washington, 98166, United States

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Spokane, Washington, 99204, United States

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Tacoma, Washington, 98405, United States

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Milwaukee, Wisconsin, 53226, United States

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Capital Federal, Buenos Aires, 1122, Argentina

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Capital Federal, Buenos Aires, 1180, Argentina

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Cordoba-Capital, Córdoba Province, 5000, Argentina

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San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

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São Paulo, São Paulo, 04020-060, Brazil

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Coquitlam, British Columbia, V3K 3P4, Canada

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Kelowna, British Columbia, V1Y 3G8, Canada

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Langley, British Columbia, Canada

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Penticton, British Columbia, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Hamilton, Ontario, L8M 1K7, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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London, Ontario, N6A 4V2, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H1L 6J5, Canada

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Montreal, Quebec, H1T 4B3, Canada

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Montreal, Quebec, H3Z 2Z3, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Québec, Quebec, G1W 4R4, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Hong Kong, Hong Kong

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Békéscsaba, H-5600, Hungary

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Budapest, H-1036, Hungary

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Debrecen, Hungary

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Kiskunhalas, H-6400, Hungary

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Nyíregyháza, Hungary

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Guadalajara, Jalisco, 44620, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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Mexico City, 6700, Mexico

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's-Hertogenbosch, 5233 VG, Netherlands

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Almere Stad, 1311 RL, Netherlands

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Geleen, 6160 BB, Netherlands

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Nijmegen, 6525 EC, Netherlands

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Krakow, 30-119, Poland

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Krakow, 31-121, Poland

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Szczecin, Poland

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Warsaw, 02-637, Poland

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Wroclaw, 53-347, Poland

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A Coruña, 15006, Spain

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Guadalajara, 19002, Spain

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Madrid, 28046, Spain

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Seville, 41009, Spain

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MeSH Terms

Conditions

Osteoarthritis; Arthritis; Pain

Interventions

PLA-695

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Argentina, Scheima@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Brazil, xavierl@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For China, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Hong Kong, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Hungary, WPBUMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Mexico, gomezzlj@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Netherlands, trials-NL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Spain, infomed@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 8, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: December 28, 2007

Record last verified: 2007-12

Locations

HK (1); HU (5); AR (4); ME (3); NL (4); PL (5); ES (4); CA (17); BR (1); US (39)