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Extension Study Of Tanezumab In Osteoarthritis

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NCT00809783

Last updated on October 4, 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.
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

- Must have participated in previous (specific) Phase 3 trials of Tanezumab in
osteoarthritis

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

- Willing to comply with scheduled visits and treatment plan Is medically fit to
participate in the trial in the judgement of the Investigator

NCT00809783
Pfizer
Terminated
Extension Study Of Tanezumab In Osteoarthritis

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[email protected]

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Extension Study Of Tanezumab In Osteoarthritis
A Phase 3, Multicenter, Randomized, Long Term Study Of The Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip
Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab
This study was terminated on 27 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: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoarthritis
  • Biological: tanezumab
    Tanezumab 10 mg
    Other Name: RN624
  • Biological: tanezumab
    Tanezumab 5 mg
    Other Name: RN624
  • Biological: tanezumab
    Tanezumab 2.5 mg
    Other Name: RN624
  • Experimental: Tanezumab 10 mg
    Tanezumab 10 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 5 mg
    Tanezumab 5 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 2.5 mg
    Tanezumab 2.5 mg
    Intervention: Biological: tanezumab
Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2147
June 2011
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

  • Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator
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
 
NCT00809783
A4091016
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

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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