Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip - NCT00809354-54650 (Clinical Trial 259851)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy259851.aspx
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| City: |
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Onalaska |
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State:
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WI |
| Zip Code: |
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54650 |
| Conditions: |
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Osteoarthritis - Arthritis |
| Purpose: |
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The purpose of this study is to investigate the long-term analgesic efficacy and safety of
tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing
partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID)
therapy.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence
x-ray grade equal to, or greater than, 2.
- Patients must be experiencing some benefit from their current stable dose regimen of
oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either
100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
- Pain level and function levels as required by the protocol at Screening and Baseline.
- Willing to discontinue all non-study pain medications for osteoarthritis except
rescue medication (acetaminophen) and not use prohibited pain medications throughout
the duration of the study except as permitted per protocol.
- Willing and able to comply with lifestyle guidelines, scheduled visits, treatment
plan, laboratory tests and other study procedures.
Exclusion Criteria:
- Pregnant women.
- BMI greater than 39.
- Fibromyalgia, regional pain caused by lumbar or cervical compression with
radiculopathy or other moderate to sever pain that may confound assessments or
self-evaluation of the pain associated with OA.
- Signs and symptoms of clinically significant cardiac disease with 6 months prior to
screening.
- Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with
residual deficits that would preclude completion of required study activities.
- History, diagnosis, signs or symptoms of clinically significant neurological and/or
psychiatric disease/disorder.
- At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%,
ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding
1.7 mg/dL (men) or 1.5 mg/dL (women).
- Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy
within 30 days prior to screening.
- Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors. |
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| Study is available at: |
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Pfizer Investigational Site
Onalaska, WI 54650
United States
Primary Contact:
Pfizer CT.gov Call Center
Phone: 1-800-718-1021 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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