Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip


Tracking Information

Start Date  ICMJEAugust 2009
Estimated Primary Completion DateSeptember 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 ICMJESame as current
Change HistoryComplete 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 ICMJESame as current

Descriptive Information

Brief Title  ICMJEAnalgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip
Official Title  ICMJEA 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEOsteoarthritis
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 Information

Estimated Enrollment  ICMJE600
Estimated Completion DateSeptember 2010
Estimated Primary Completion DateSeptember 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).
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEAustria,   France,   Germany,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00864097
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA4091017
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer