Tanezumab in Osteoarthritis of the Knee

NCT00733902

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[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 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

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Arthritis, OsteoarthritisTanezumab in Osteoarthritis of the Knee
NCT00733902
  1. Phoenix, Arizona
  2. Danbury, Connecticut
  3. Stamford, Connecticut
  4. Newark, Delaware
  5. Clearwater, Florida
  6. DeLand, Florida
  7. Delray Beach, Florida
  8. Jacksonville, Florida
  9. Largo, Florida
  10. Miami, Florida
  11. Miami, Florida
  12. Orlando, Florida
  13. Palm Harbor, Florida
  14. Pembroke Pines, Florida
  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
  29. Monroe, Louisiana
  30. Auburn, Maine
  31. Frederick, Maryland
  32. Wheaton, Maryland
  33. Mansfield, Massachusetts
  34. Peabody, Massachusetts
  35. Worcester, Massachusetts
  36. Ann Arbor, Michigan
  37. St. Clair Shores, Michigan
  38. Edina, Minnesota
  39. St. Louis, Missouri
  40. Las Vegas,, Nevada
  41. Berlin, New Jersey
  42. Albuquerque, New Mexico
  43. Albuquerque, New Mexico
  44. New York, New York
  45. Plainview, New York
  46. Rochester, New York
  47. Charlotte, North Carolina
  48. Greensboro, North Carolina
  49. Winston-Salem, North Carolina
  50. Cincinnati, Ohio
  51. Middleburg Heights, Ohio
  52. Zanesville, Ohio
  53. Oklahoma City, Oklahoma
  54. Portland, Oregon
  55. Bethlehem, Pennsylvania
  56. Downingtown, Pennsylvania
  57. Duncansville, Pennsylvania
  58. Rapid City, South Dakota
  59. Johnson City, Tennessee
  60. Austin, Texas
  61. Dallas, Texas
  62. San Antonio, Texas
  63. San Antonio, Texas
  64. Charlottesville, Virginia
  65. Yakima, Washington
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
  20. Coral Gables, Florida
  21. DeLand, Florida
  22. Jacksonville, Florida
  23. Longwood, Florida
  24. Miami, Florida
  25. Palm Harbor, Florida
  26. Pembroke Pines, Florida
  27. Port Orange, Florida
  28. Tamarac, Florida
  29. West Palm Beach, Florida
  30. Atlanta, Georgia
  31. Decatur, Georgia
  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
  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
  54. Omaha, Nebraska
  55. Las Vegas,, Nevada
  56. Las Vegas, Nevada
  57. Berlin, New Jersey
  58. Albuquerque, New Mexico
  59. Albuquerque, New Mexico
  60. New York, New York
  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
  83. Norfolk, Virginia
  84. Portsmouth, Virginia
  85. Yakima, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
Detailed Description Not 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 Date September 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 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 January 2011

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