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
Tracking InformationStart Date ICMJE | February 2009 |
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Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: December 16, 2008) | - WOMAC Physical Function subscale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Western Ontario and McMaster Universities Index (WOMAC) Pain subscale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00809354 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: January 9, 2009) | - Adverse events [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
- SF-36v2 Health Survey (8 domains plus Physical Component Summary and Mental Component Summary) [ Time Frame: Weeks 12, 24, 40 and 56 ] [ Designated as safety issue: No ]
- Patient Global Assessment of Arthritis [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 ] [ Designated as safety issue: No ]
- Measurement of plasma tanezumab concentrations [ Time Frame: Weeks 16, 24, 40 and 56 ] [ Designated as safety issue: No ]
- WOMAC pain, physical function and stiffness subscales [ Time Frame: Weeks 2, 4, 8, 12, 24,32, 40, 48 and 56 ] [ Designated as safety issue: No ]
- Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]
- Radiographic assessment of index joint (knee or hip) [ Time Frame: Screening period and Week 56 ] [ Designated as safety issue: Yes ]
- Safety (laboratories for chemistry, hematology urinalysis, ECGs, physical exams, vital signs, neurologic exams, serum anti-drug antibody assessments [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
- Pregnancy tests (where applicable) [ Time Frame: Weeks 8, 16, 24, 32, 40, 48 and 56 ] [ Designated as safety issue: Yes ]
- Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) [ Time Frame: Weeks 24 and 56 ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE (submitted: December 16, 2008) | - Adverse events [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
- SF-36v2 Health Survey (8 domains plus Physical Component Summary and Mental Component Summary) [ Time Frame: Weeks 12, 24, 40 and 56 ] [ Designated as safety issue: No ]
- Patient Global Assessment of Arthritis [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 ] [ Designated as safety issue: No ]
- Measurement of plama tanezumab concentrations [ Time Frame: Weeks 16, 24, 40 and 56 ] [ Designated as safety issue: No ]
- WOMAC pain, physical function and stiffness subscales [ Time Frame: Weeks 2, 4, 8, 12, 24,32, 40, 48 and 56 ] [ Designated as safety issue: No ]
- Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]
- Radiographic assessment of index joint (knee or hip) [ Time Frame: Screening period and Week 56 ] [ Designated as safety issue: Yes ]
- Safety (laboratories for chemistry, hematology urinalysis, ECGs, physical exams, vital signs, neurologic exams, serum anti-drug antibody assessments [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
- Pregnancy tests (where applicable) [ Time Frame: Weeks 8, 16, 24, 32, 40, 48 and 56 ] [ Designated as safety issue: Yes ]
- Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) [ Time Frame: Weeks 24 and 56 ] [ Designated as safety issue: No ]
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Descriptive InformationBrief 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 |
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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 |
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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. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | |
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Intervention ICMJE | - Drug: NSAID
IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks - Biological: tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56 - Biological: tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56 - Biological: tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48) - Drug: NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks - Biological: tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 48)
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Study Arms / Comparison Groups | - IV Placebo + NSAID: Active Comparator
Oral NSAID Intervention: Drug: NSAID - Tanezumab 5 mg: Experimental
IV tanezumab 5 mg every 8 weeks (through Week 48) Intervention: Biological: tanezumab - Tanezumab 10 mg: Experimental
IV tanezumab 10 mg every 8 weeks (through Week 48) Intervention: Biological: tanezumab - Tanezumab 5 mg + NSAID: Experimental
IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks Interventions: - Biological: tanezumab
- Drug: NSAID
- Tanezumab 10 mg + NSAID: Experimental
IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks Interventions: - Biological: tanezumab
- Drug: NSAID
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Recruitment InformationEstimated Enrollment ICMJE | 2500 |
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Estimated Completion Date | December 2010 |
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Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | 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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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | | |
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Location Countries ICMJE | United States, Canada, Colombia, India, Korea, Republic of, Mexico, Netherlands, Philippines, Russian Federation, South Africa, Spain, Ukraine |
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Administrative InformationNCT ID ICMJE | NCT00809354 |
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
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Study ID Numbers ICMJE | A4091025 |
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Study Sponsor ICMJE | Pfizer |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Pfizer CT.gov Call Center | Pfizer | |
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Information Provided By | Pfizer |
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