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Tanezumab and Nerve Function In Arthritis Patients

Last updated on May 10, 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

- BMI less or equal to 39 kg/m2

- Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies

- 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 consent in writing to participate in the study.

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

- Untreated, uncontrolled diseases,

- Unwilling or unable to discontinue the use of prohibited medications, including other
pain medications, during the screening period and during the study,

- Significant cardiac disease within the past 6 months

- Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis,
stroke) or signs of neuropathy at screening

- Known bleeding disorder or anticoagulation therapy

- Planned surgery during the study period

- History of alcoholism or drug abuse in the past 2 years

- Unable to use acetaminophen

- Use of a biologic (including live vaccines, with the exception of Flumist) within the
past 3 months

- Allergic reaction to a biologic or an antibody in the past

- Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test

- Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.

- Medical condition that may interfere with study endpoints or safety of the subject as
determined by the investigator.

NCT00863772
Pfizer
Terminated
Tanezumab and Nerve Function In Arthritis Patients

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Tanezumab and Nerve Function In Arthritis Patients
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Tanezumab On Peripheral Nerve Function In Patients With Osteoarthritis
Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.
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: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoarthritis
  • Biological: tanezumab
    5 mg dose Intravenously every 8 weeks for duration of study
  • Biological: tanezumab
    10 mg dose Intravenously every 8 weeks for duration of study
  • Other: Placebo
    Placebo, Intravenously, every 8 weeks for duration of study
  • 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
220
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI less or equal to 39 kg/m2
  • Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
  • 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 consent in writing to participate in the study.

Exclusion Criteria:

  • Untreated, uncontrolled diseases,
  • Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
  • Significant cardiac disease within the past 6 months
  • Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening
  • Known bleeding disorder or anticoagulation therapy
  • Planned surgery during the study period
  • History of alcoholism or drug abuse in the past 2 years
  • Unable to use acetaminophen
  • Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
  • Allergic reaction to a biologic or an antibody in the past
  • Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
  • Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
  • Medical condition that may interfere with study endpoints or safety of the subject as determined by 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
Canada,   United States
 
NCT00863772
A4091026
No
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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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