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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00396955 |
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 |
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Osteoarthritis |
Drug: PLA-695 |
Phase II |
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 |
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) |
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.
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: The main inclusion criteria is listed below, additional inclusion criteria is in the protocol.
Exclusion Criteria: These are some of the main exclusion criteria for the the study. Additional exclusion are included in the protocol.
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 |
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 |
osteoarthritis arthritis pain |
Osteoarthritis, Knee Naproxen Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Pain Rheumatic Diseases |