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A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

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NCT00994890

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis, Hip 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 based on American College of Rheumatology criteria
with a radiographic (X ray) confirmation (a 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

- Body mass index (BMI) of >39 kg/m2;

- Pregnancy or intent to become pregnant

- Planned surgical procedure during the duration of the study

- History of clinically significant cardiovascular, central nervous system or
psychiatric disease

- Previous exposure to exogenous NGF or to an anti NGF antibody;

- Use of biologics other than study medication, Live or live-attenuated intranasal
vaccines (eg, Flumist), are allowable exceptions

NCT00994890
Pfizer
Terminated
A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections
A Multicenter, Randomized, Double-Blind, Long Term Study Of The Safety Of Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip
This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.
Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
  • Biological: Tanezumab 2.5 mg
    Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
    Other Name: Biological
  • Biological: Tanezumab 5 mg
    Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
    Other Name: Biological
  • Biological: Tanezumab 10 mg
    Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
    Other Name: Biological
  • Experimental: Tanezumab 2.5 mg
    Intervention: Biological: Tanezumab 2.5 mg
  • Experimental: Tanezumab 5 mg
    Intervention: Biological: Tanezumab 5 mg
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: Tanezumab 10 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
679
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ?2);

Exclusion Criteria:

  • Body mass index (BMI) of >39 kg/m2;
  • Pregnancy or intent to become pregnant
  • Planned surgical procedure during the duration of the study
  • History of clinically significant cardiovascular, central nervous system or psychiatric disease
  • Previous exposure to exogenous NGF or to an anti NGF antibody;
  • Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00994890
A4091043
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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