Tanezumab In Osteoarthritis Of The Knee (2)

NCT00830063

Last updated date
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Contact
1-800-718-1021

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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

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Arthritis, OsteoarthritisTanezumab in Osteoarthritis of the Knee
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  12. Miami, Florida
  13. Miami, Florida
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  18. Pinellas Park, Florida
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  20. Saint Petersburg, Florida
  21. West Palm Beach, Florida
  22. Atlanta, Georgia
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  24. Fort Valley, Georgia
  25. Marietta, Georgia
  26. Woodstock, Georgia
  27. Woodstock, Georgia
  28. Boise, Idaho
  29. Springfield, Illinois
  30. South Bend, Indiana
  31. South Bend, Indiana
  32. Valparaiso, Indiana
  33. Lexington, Kentucky
  34. Lexington, Kentucky
  35. Louisville, Kentucky
  36. Baton Rouge, Louisiana
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  38. Monroe, Louisiana
  39. Auburn, Maine
  40. Baltimore, Maryland
  41. Frederick, Maryland
  42. Wheaton, Maryland
  43. Mansfield, Massachusetts
  44. Peabody, Massachusetts
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  46. Ann Arbor, Michigan
  47. Saint Clair Shores, Michigan
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  77. Dallas, Texas
  78. San Antonio, Texas
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  80. San Antonio, Texas
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Arthritis, OsteoarthritisTanezumab In Osteoarthritis Of The Knee (2)
NCT00830063
  1. Anniston, Alabama
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  8. Tucson, Arizona
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  10. Hot Springs, Arkansas
  11. Beverly Hills, California
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  45. Louisville, Kentucky
  46. Baton Rouge, Louisiana
  47. Auburn, Maine
  48. Frederick, Maryland
  49. Wheaton, Maryland
  50. Worcester, Massachusetts
  51. St. Clair Shores, Michigan
  52. Edina, Minnesota
  53. St. Louis, Missouri
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  56. Las Vegas, Nevada
  57. Berlin, New Jersey
  58. Albuquerque, New Mexico
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  61. Rochester, New York
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  64. Greensboro, North Carolina
  65. Fargo, North Dakota
  66. Cincinnati, Ohio
  67. Middleburg Heights, Ohio
  68. Zanesville, Ohio
  69. Oklahoma City, Oklahoma
  70. Duncansville, Pennsylvania
  71. West Reading, Pennsylvania
  72. Mount Pleasant, South Carolina
  73. Rapid City, South Dakota
  74. Johnson City, Tennessee
  75. Kingsport, Tennessee
  76. Austin, Texas
  77. Dallas, Texas
  78. Houston, Texas
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary The 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 Description Not 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 Date May 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 Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP