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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Graz, , A-8036 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00864097
Pfizer
Terminated
Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

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Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip
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
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.
This study was terminated on 16 Nov 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
  • 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)
  • Other: IV placebo
    IV placebo to match tanezumab every 8 weeks (through Week 16)
  • Experimental: Tanezumab 10 mg + diclofenac
    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
  • Experimental: Tanezumab 5 mg + diclofenac
    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
  • Experimental: Tanezumab 2.5 mg + diclofenac
    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
  • Placebo Comparator: IV placebo + diclofenac
    IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
    Interventions:
    • Drug: diclofenac
    • Other: IV placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
607
November 2010
November 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 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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom
 
 
NCT00864097
A4091017
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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