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
ABOUT THIS STUDY
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- 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.
- 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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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | A Phase 3, Multi-Center, Randomized, Double-Blind, Controlled Study Of The 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 | |||
Brief Summary | 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. | |||
Detailed Description | This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 2720 | |||
Original Estimated Enrollment ICMJE | 2500 | |||
Actual Study Completion Date ICMJE | October 2010 | |||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Colombia, India, Korea, Republic of, Mexico, Netherlands, Philippines, Russian Federation, South Africa, Spain, Ukraine, United States | |||
Removed Location Countries | Brazil | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00809354 | |||
Other Study ID Numbers ICMJE | A4091025 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |