Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip
Tracking InformationStart Date ICMJE | August 2009 |
---|
Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) |
---|
Current Primary Outcome Measures ICMJE (submitted: March 17, 2009) | - Western Ontario and McMaster Universities (WOMAC) Pain Subscale [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- WOMAC Physical Function Subscale [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Patient Global Assessment of Osteoarthritis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
|
---|
Original Primary Outcome Measures ICMJE | Same as current |
---|
Change History | Complete list of historical versions of study NCT00864097 on ClinicalTrials.gov Archive Site |
---|
Current Secondary Outcome Measures ICMJE (submitted: March 17, 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, 32 ] [ Designated as safety issue: No ]
- Patient Global Assessment of Osteoarthritis [ Time Frame: Weeks 2, 4, 8, 12, 16, 32 ] [ Designated as safety issue: No ]
- WOMAC pain, physical function and stiffness subscales [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32 ] [ Designated as safety issue: No ]
- Average of daily pain scores in index knee or hip [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32 ] [ Designated as safety issue: No ]
- EQ-5D [ Time Frame: Weeks 24, 32 ] [ Designated as safety issue: No ]
- Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]
- Safety (laboratories for chemistry, hematology,urinalysis; ECGs; physical exams; vital signs; neurologic exams; serum anti-drug antibody assessments; pregnancy tests (where applicable) [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
|
---|
Original Secondary Outcome Measures ICMJE | Same as current |
---|
Descriptive InformationBrief Title ICMJE | Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip |
---|
Official Title ICMJE | A Phase 3, Randomized, Double-Blind, Controlled, Multi-Center Study Of The Analgesic Efficacy And Safety Of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip |
---|
Brief Summary | The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy. |
---|
Detailed Description | |
---|
Study Phase | Phase III |
---|
Study Type ICMJE | Interventional |
---|
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
---|
Condition ICMJE | Osteoarthritis |
---|
Intervention ICMJE | - Biological: tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 16) - Drug: diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks - Biological: tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 16) - Biological: tanezumab
IV tanezumab 2.5 mg every 8 weeks (through Week 16)
|
---|
Study Arms / Comparison Groups | - Tanezumab 10 mg + diclofenac: Experimental
IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) Interventions: - Biological: tanezumab
- Drug: diclofenac
- Tanezumab 5 mg + diclofenac: Experimental
IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) Interventions: - Biological: tanezumab
- Drug: diclofenac
- Tanezumab 2.5 mg + diclofenac: Experimental
IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) Interventions: - Biological: tanezumab
- Drug: diclofenac
- IV placebo + diclofenac: Active Comparator
IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) Intervention: Drug: diclofenac
|
---|
Recruitment InformationEstimated Enrollment ICMJE | 600 |
---|
Estimated Completion Date | September 2010 |
---|
Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) |
---|
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 diclofenac 150 mg/day and be tolerating their diclofenac regimen.
- Pain and function levels as required by the protocol at Screening and Baseline.
- Willing to discontinue all non-study pain medications throughout 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.
- History of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections, neuropathic disorders, avascular necrosis, Paget's disease or tumors.
- Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA.
- Signs and symptoms of clinically significant cardiac disease within 6 months prior to screening.
- Diagnosis or 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 150 micro-mol/L in men or 133 micro-mol/L in women.
- Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to Screening.
- Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).
|
---|
Gender | Both |
---|
Ages | 18 Years and older |
---|
Accepts Healthy Volunteers | No |
---|
Contacts ICMJE | Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | | |
|
---|
Location Countries ICMJE | Austria, France, Germany, Poland, Romania, Russian Federation, Spain, Sweden, Ukraine, United Kingdom |
---|
Administrative InformationNCT ID ICMJE | NCT00864097 |
---|
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
---|
Study ID Numbers ICMJE | A4091017 |
---|
Study Sponsor ICMJE | Pfizer |
---|
Collaborators ICMJE | |
---|
Investigators ICMJE | Study Director: | Pfizer CT.gov Call Center | Pfizer | |
|
---|
Information Provided By | Pfizer |
---|
|