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Tanezumab In Osteoarthritis Of The Hip Or Knee

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209 United States
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
18-75 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 Kellgren-Lawrence x-ray grade of 2

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

- pregnancy or intent to become pregnant

- BMI greater than 39

- other severe pain, significant cardiac, neurological or psychiatric disease

NCT00985621
Pfizer
Terminated
Tanezumab In Osteoarthritis Of The Hip Or Knee

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Tanezumab In Osteoarthritis Of The Hip Or Knee
A Phase 3 Randomized, Double-Blind, Placebo- And Oxycodone-Controlled, Multicenter Study Of The Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip
The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis
This study was terminated on 13 Dec 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 10 mg
    tanezumab 10 mg one dose at weeks 0 and 8
  • Biological: tanezumab 5 mg
    tanezumab 5 mg one dose at weeks 0 and 8
  • Drug: oxycodone
    oxycodone CR, 10-40 mg q12h
  • Other: placebo
    placebo
  • Experimental: 1
    Intervention: Biological: tanezumab 10 mg
  • Experimental: 2
    Intervention: Biological: tanezumab 5 mg
  • Active Comparator: 3
    Intervention: Drug: oxycodone
  • Placebo Comparator: 4
    Intervention: Other: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
600
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

  • pregnancy or intent to become pregnant
  • BMI greater than 39
  • other severe pain, significant cardiac, neurological or psychiatric disease
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Denmark,   Germany,   Poland,   Spain,   Sweden,   United States
Romania
 
NCT00985621
A4091030
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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