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Tanezumab in Osteoarthritis Of The Hip

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, 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 hip according to ACR criteria with 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 Hip
injections, arthroplasty or replacement 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

- BMI greater than 39

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

NCT00744471
Pfizer
Completed
Tanezumab in Osteoarthritis Of The Hip

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Tanezumab in Osteoarthritis Of The Hip
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Hip
The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Arthritis
  • Osteoarthritis
  • Osteoarthritis, Hip
  • Biological: tanezumab
    Tanezumab 10 mg IV every 8 weeks
  • Biological: tanezumab
    Tanezumab 5mg IV every 8 weeks
  • Biological: tanezumab
    Tanezumab 2.5 mg IV every 8 weeks.
  • Biological: Placebo
    Placebo to match tanezumab IV every 8 weeks
  • Experimental: Tanezumab 10 mg
    Tanezumab 10 mg IV every 8 weeks
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 5 mg
    Tanezumab 5mg IV every 8 weeks
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 2.5 mg
    Tanezumab 2.5 mg IV every 8 weeks.
    Intervention: Biological: tanezumab
  • Experimental: Placebo
    Placebo
    Intervention: Biological: Placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
627
June 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Osteoarthritis of the hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement 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
  • 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
 
 
NCT00744471
A4091014
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 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.

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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