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Tanezumab in Osteoarthritis of the Knee

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NCT00733902

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, 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 according to ACR criteria with a Kellgren-Lawrence x-ray
grade of 2.

- Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain
medications have not provided adequate pain relief or are candidates for knee
injections arthroplasty or replace surgery.

- Pain level and function levels as required by the protocol at Screening and Baseline.

- Willing to discontinue pain medications (acetaminophen will be permitted up to a
certain level) before and during the study.

- Must agree to the contraceptive requirements of the protocol if applicable.

- Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

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

- Pregnancy or intent to become pregnant during the study

- BMI greater than 39

- other severe pain, significant cardiac, neurological or psychological conditions, or
above the protocol limits for laboratory and blood pressure results

NCT00733902
Pfizer
Completed
Tanezumab in Osteoarthritis of the Knee

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Tanezumab in Osteoarthritis of the Knee
A Phase 3 Randomized, Double Blind, Placebo-Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Arthritis
  • Osteoarthritis
  • Biological: tanezumab
    IV tanezumab 10 mg at 1 dose every 8 weeks
  • Biological: tanezumab
    IV tanezumab 5 mg at 1 dose every 8 weeks
  • Biological: tanezumab
    IV tanezumab 2.5 mg at 1 dose every 8 weeks
  • Biological: Placebo
    IV placebo to match tanezumab at 1 dose every 8 weeks
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 5 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 2.5 mg
    Intervention: Biological: tanezumab
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
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.
 
Completed
697
November 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
  • Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
  • Pain level and function levels as required by the protocol at Screening and Baseline.
  • Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
  • Must agree to the contraceptive requirements of the protocol if applicable.
  • Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

Exclusion Criteria:

  • Pregnancy or intent to become pregnant during the study
  • BMI greater than 39
  • other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00733902
A4091011
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 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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