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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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00809354
Pfizer
Terminated
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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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
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis
  • Arthritis
  • 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)
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2720
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Colombia,   India,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Russian Federation,   South Africa,   Spain,   Ukraine,   United States
Brazil
 
NCT00809354
A4091025
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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