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Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
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

- Patients must consent in writing to participate in the study.

- Patients must be willing to comply with study visit schedule and study requirements,
including, for women of child-bearing potential or male patients with female partners
of child-bearing potential, the use of 2 forms of birth control, one of which is a
barrier method.

- Patients must have participated in the A4091026 study.

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

- Withdrawn from the A4091026 study for an adverse event or serious adverse event.

- Pregnant women, lactating mothers, women suspected of being pregnant, and women who
wish to be pregnant during the course of clinical study.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the patient
inappropriate for entry into this study.

NCT00960804
Pfizer
Terminated
Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients

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Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter, Long-Term Safety Study Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip
Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves
This study was terminated on 11 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: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoarthritis
  • Biological: Tanezumab
    IV, 5 mg dose, q 8 weeks, for up to 80 weeks
  • Biological: Tanezumab
    IV, 10 mg dose, q 8 weeks, for up to 80 weeks
  • Other: Placebo
    IV, q 8 weeks, for up to 80 weeks
  • Experimental: Tanezumab 5 mg
    Intervention: Biological: Tanezumab
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: Tanezumab
  • Placebo Comparator: Placebo
    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
21
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must consent in writing to participate in the study.
  • Patients must be willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
  • Patients must have participated in the A4091026 study.

Exclusion Criteria:

  • Withdrawn from the A4091026 study for an adverse event or serious adverse event.
  • Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
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
Canada,   United States
 
NCT00960804
A4091040
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

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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