Tanezumab In Osteoarthritis Of The Knee (2)

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NCT00830063

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Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
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Contact
1-800-718-1021
[email protected]
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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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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 NCT00733902
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  3. Stamford, Connecticut
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  5. Clearwater, Florida
  6. DeLand, Florida
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  15. Pinellas Park, Florida
  16. Port Orange, Florida
  17. West Palm Beach, Florida
  18. Atlanta, Georgia
  19. Decatur, Georgia
  20. Fort Valley, Georgia
  21. Woodstock, Georgia
  22. Boise, Idaho
  23. Springfield, Illinois
  24. South Bend, Indiana
  25. Valparaiso, Indiana
  26. Lexington, Kentucky
  27. Loiusville, Kentucky
  28. Baton Rouge, Louisiana
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  30. Auburn, Maine
  31. Frederick, Maryland
  32. Wheaton, Maryland
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  59. Johnson City, Tennessee
  60. Austin, Texas
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Arthritis, OsteoarthritisTanezumab In Osteoarthritis Of The Knee (2) NCT00830063
  1. Anniston, Alabama
  2. Mesa, Arizona
  3. Paradise Valley, Arizona
  4. Peoria, Arizona
  5. Phoenix, Arizona
  6. Phoenix, Arizona
  7. Tempe, Arizona
  8. Tucson, Arizona
  9. Tuscon, Arizona
  10. Hot Springs, Arkansas
  11. Beverly Hills, California
  12. Fresno, California
  13. Huntington Beach, California
  14. Sacramento, California
  15. Thousand Oaks, California
  16. Stamford, Connecticut
  17. Newark, Delaware
  18. Clearwater, Florida
  19. Clearwater, Florida
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  28. Tamarac, Florida
  29. West Palm Beach, Florida
  30. Atlanta, Georgia
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  32. Marietta, Georgia
  33. Woodstock, Georgia
  34. Woodstock, Georgia
  35. Boise, Idaho
  36. Chicago, Illinois
  37. Chicago, Illinois
  38. Morton Grove, Illinois
  39. Morton, Illinois
  40. Springfield, Illinois
  41. Valparaiso, Indiana
  42. Ames, Iowa
  43. West Des Moines, Iowa
  44. Wichita, Kansas
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  46. Baton Rouge, Louisiana
  47. Auburn, Maine
  48. Frederick, Maryland
  49. Wheaton, Maryland
  50. Worcester, Massachusetts
  51. St. Clair Shores, Michigan
  52. Edina, Minnesota
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  55. Las Vegas,, Nevada
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  61. Rochester, New York
  62. Roslyn, New York
  63. Charlotte, North Carolina
  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
  79. Houston, Texas
  80. San Antonio, Texas
  81. San Antonio, Texas
  82. Orem, Utah
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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