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Tanezumab In Osteoarthritis Of The Knee (2)

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NCT00830063

Last updated on November 11, 2019
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 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 Kellgren-Lawrence x-ray grade of 2

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

- Pregnancy or intent to become pregnant

- BMI greater than 39

- other severe pain, significant cardiac, neurologic or cardiac disease

NCT00830063
Pfizer
Completed
Tanezumab In Osteoarthritis Of The Knee (2)

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Descriptive Information
Brief Title  ICMJE Tanezumab In Osteoarthritis Of The Knee (2)
Official Title  ICMJE A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee
Brief SummaryThe purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Arthritis
  • Osteoarthritis
Intervention  ICMJE
  • Biological: tanezumab 10 mg
    tanezumab 10 mg one dose at weeks 0 and 8
  • Biological: tanezumab 5 mg
    tanezumab 5 mg one dose at weeks 0 and 8
  • Drug: naproxen
    naproxen 1000 mg daily for 16 weeks
  • Other: placebo
    placebo to match tanezumab and naproxen dosing
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: tanezumab 10 mg
  • Experimental: 2
    Intervention: Biological: tanezumab 5 mg
  • Active Comparator: 3
    Intervention: Drug: naproxen
  • Placebo Comparator: 4
    Intervention: Other: 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: July 29, 2010)		848
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2009)		800
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion DateMay 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

  • Pregnancy or intent to become pregnant
  • BMI greater than 39
  • other severe pain, significant cardiac, neurologic or cardiac disease
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 NCT00830063
Other Study ID Numbers  ICMJE A4091015
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 DateJune 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

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Contact

[email protected]

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