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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

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00809354
Pfizer
Terminated
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

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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