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Tanezumab in Osteoarthritis of the Knee

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023 United States
Contact
1-800-718-1021
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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Descriptive Information
Brief Title  ICMJE Tanezumab in Osteoarthritis of the Knee
Official Title  ICMJE 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
Brief SummaryTest the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Arthritis
  • Osteoarthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2009)
697
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2008)
600
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion DateSeptember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00733902
Other Study ID Numbers  ICMJE A4091011
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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