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A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee
This study has been terminated.
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00396955
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: PLA-695
Phase II

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Naproxen Naproxen sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind Comparison of 4 Dose Regimens of Pla-695, Naproxen, and Placebo Administered Daily for 6 Weeks in Subjects With Active Osteoarthritis of the Knee

Further study details as provided by Wyeth:

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

Secondary Outcome Measures:
  • WOMAC VAS walking pain at weeks 1, 2, 3, 4, and 5; WOMAC pain, stiffness, and function subscales, and composite score; Investigators’ Efficacy Evaluation; Investigators’ overall assessment; Joint tenderness. Subjects’ Efficacy Evaluation.

Estimated Enrollment: 560
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This is a multi-center, randomized, double-blind, double-dummy, parallel, placebo- and positive-control (naproxen), dose-ranging study to assess the efficacy and safety of 3 oral doses of PLA-695 administered QD and 1 dose of PLA-695 administered BID for 6 weeks. Subjects will be randomized to 1 of 6 treatment groups: PLA-695 50 mg, 200 mg, or 400 mg QD, PLA-695 200 mg BID, placebo, or naproxen 500 mg BID. Subjects will undergo a washout period of 2 to 14 days. The number of days for washout will be determined by the pre-study NSAID of each subject. Subjects who washout from previous therapy with an increase in signs and symptoms of OA will be randomly assigned to receive PLA-695.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: The main inclusion criteria is listed below, additional inclusion criteria is in the protocol.

  • 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.

Exclusion Criteria: These are some of the main exclusion criteria for the the study. Additional exclusion are included in the protocol.

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396955

  Show 83 Study Locations
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
Principal Investigator: 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
  More Information

Responsible Party: Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers: 3175A1-202
Study First Received: November 7, 2006
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00396955  
Health Authority: Brazil: National Committee of Ethics in Research;   Brazil: Ministry of Health;   Canada: Ethics Review Committee;   Canada: Health Canada;   China: Ministry of Health;   France: Afssaps - French Health Products Safety Agency;   France: Institutional Ethical Committee;   France: Ministry of Health;   France: National Consultative Ethics Committee for Health and Life Sciences;   Hong Kong: Department of Health;   Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee;   Hungary: National Institute of Pharmacy;   Mexico: Ethics Committee;   Mexico: Federal Commission for Protection Against Health Risks;   Netherlands: Independent Ethics Committee;   Netherlands: Medical Ethics Review Committee (METC);   Poland: Ministry of Health;   Spain: Ministry of Health;   Spain: Ministry of Health and Consumption;   United States: Food and Drug Administration

Keywords provided by Wyeth:
osteoarthritis
arthritis
pain

Study placed in the following topic categories:
Osteoarthritis, Knee
Naproxen
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Pain
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009