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Trial record 1 of 1 for:    NCT00809354
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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

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ClinicalTrials.gov Identifier: NCT00809354
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : December 17, 2008
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 16, 2008
First Posted Date  ICMJE December 17, 2008
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
  • WOMAC Physical Function subscale [ Time Frame: Week 16 ]
  • Western Ontario and McMaster Universities Index (WOMAC) Pain subscale [ Time Frame: Week 16 ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00809354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
  • Adverse events [ Time Frame: All weeks ]
  • SF-36v2 Health Survey (8 domains plus Physical Component Summary and Mental Component Summary) [ Time Frame: Weeks 12, 24, 40 and 56 ]
  • Patient Global Assessment of Arthritis [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 ]
  • Measurement of plasma tanezumab concentrations [ Time Frame: Weeks 16, 24, 40 and 56 ]
  • WOMAC pain, physical function and stiffness subscales [ Time Frame: Weeks 2, 4, 8, 12, 24,32, 40, 48 and 56 ]
  • Time to discontinuation [ Time Frame: All weeks ]
  • Radiographic assessment of index joint (knee or hip) [ Time Frame: Screening period and Week 56 ]
  • Safety (laboratories for chemistry, hematology urinalysis, ECGs, physical exams, vital signs, neurologic exams, serum anti-drug antibody assessments [ Time Frame: All weeks ]
  • Pregnancy tests (where applicable) [ Time Frame: Weeks 8, 16, 24, 32, 40, 48 and 56 ]
  • Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) [ Time Frame: Weeks 24 and 56 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
  • Adverse events [ Time Frame: All weeks ]
  • SF-36v2 Health Survey (8 domains plus Physical Component Summary and Mental Component Summary) [ Time Frame: Weeks 12, 24, 40 and 56 ]
  • Patient Global Assessment of Arthritis [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 ]
  • Measurement of plama tanezumab concentrations [ Time Frame: Weeks 16, 24, 40 and 56 ]
  • WOMAC pain, physical function and stiffness subscales [ Time Frame: Weeks 2, 4, 8, 12, 24,32, 40, 48 and 56 ]
  • Time to discontinuation [ Time Frame: All weeks ]
  • Radiographic assessment of index joint (knee or hip) [ Time Frame: Screening period and Week 56 ]
  • Safety (laboratories for chemistry, hematology urinalysis, ECGs, physical exams, vital signs, neurologic exams, serum anti-drug antibody assessments [ Time Frame: All weeks ]
  • Pregnancy tests (where applicable) [ Time Frame: Weeks 8, 16, 24, 32, 40, 48 and 56 ]
  • Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) [ Time Frame: Weeks 24 and 56 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Osteoarthritis
  • Arthritis
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)
Study Arms  ICMJE
  • Active Comparator: IV Placebo + NSAID
    Oral NSAID
    Intervention: Drug: NSAID
  • Experimental: Tanezumab 5 mg
    IV tanezumab 5 mg every 8 weeks (through Week 48)
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 10 mg
    IV tanezumab 10 mg every 8 weeks (through Week 48)
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 5 mg + NSAID
    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
  • Experimental: Tanezumab 10 mg + NSAID
    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
Publications *

*   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
 (submitted: November 22, 2010)
2720
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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