Tanezumab in Osteoarthritis of the Knee

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NCT00733902

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Study Location
Arizona Research Center, Inc.
Phoenix, Arizona, 85023, United States
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Contact
1-800-718-1021
[email protected]
Related Links

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
18-99 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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Pfizer Clinical Trials Contact Center

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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. Clearwater, Florida
  7. DeLand, Florida
  8. DeLand, Florida
  9. Delray Beach, Florida
  10. Delray Beach, Florida
  11. Jacksonville, Florida
  12. Miami, Florida
  13. Miami, Florida
  14. Miami, Florida
  15. Orlando, Florida
  16. Palm Harbor, Florida
  17. Pembroke Pines, Florida
  18. Pinellas Park, Florida
  19. Port Orange, Florida
  20. Saint Petersburg, Florida
  21. West Palm Beach, Florida
  22. Atlanta, Georgia
  23. Decatur, Georgia
  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
  37. Baton Rouge, Louisiana
  38. Monroe, Louisiana
  39. Auburn, Maine
  40. Baltimore, Maryland
  41. Frederick, Maryland
  42. Wheaton, Maryland
  43. Mansfield, Massachusetts
  44. Peabody, Massachusetts
  45. Worcester, Massachusetts
  46. Ann Arbor, Michigan
  47. Saint Clair Shores, Michigan
  48. Edina, Minnesota
  49. Edina, Minnesota
  50. Saint Louis, Missouri
  51. Las Vegas, Nevada
  52. Berlin, New Jersey
  53. Albuquerque, New Mexico
  54. Albuquerque, New Mexico
  55. Elmira, New York
  56. Ithaca, New York
  57. New York, New York
  58. Plainview, New York
  59. Rochester, New York
  60. Charlotte, North Carolina
  61. Greensboro, North Carolina
  62. Raleigh, North Carolina
  63. Winston-Salem, North Carolina
  64. Cincinnati, Ohio
  65. Middleburg Heights, Ohio
  66. Zanesville, Ohio
  67. Oklahoma City, Oklahoma
  68. Beaverton, Oregon
  69. Portland, Oregon
  70. Portland, Oregon
  71. Bethlehem, Pennsylvania
  72. Downingtown, Pennsylvania
  73. Duncansville, Pennsylvania
  74. Rapid City, South Dakota
  75. Johnson City, Tennessee
  76. Austin, Texas
  77. Dallas, Texas
  78. San Antonio, Texas
  79. San Antonio, Texas
  80. San Antonio, Texas
  81. Charlottesville, Virginia
  82. 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 January 14, 2010
Actual Primary Completion Date August 24, 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 to 99 Years   (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
P3 OA KNEE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2021

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