Tanezumab in Osteoarthritis Of The Hip

NCT00744471

Last updated date
Study Location
Horizon Research Group
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, Osteoarthritis, Hip 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 hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement 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


- BMI greater than 39


- Other severe pain, significant cardiac, neurological or psychological conditions, or
above the protocol limits for laboratory and blood pressure results

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Arthritis, Osteoarthritis, Hip OsteoarthritisTanezumab in Osteoarthritis Of The Hip
NCT00744471
  1. Mobile, Alabama
  2. Paradise Valley, Arizona
  3. Peoria, Arizona
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Phoenix, Arizona
  7. Tucson, Arizona
  8. Tucson, Arizona
  9. Tucson, Arizona
  10. Hot Springs, Arkansas
  11. Burbank, California
  12. Escondido, California
  13. Huntington Beach, California
  14. Santa Ana, California
  15. Danbury, Connecticut
  16. Stamford, Connecticut
  17. Newark, Delaware
  18. Clearwater, Florida
  19. Clearwater, Florida
  20. DeLand, Florida
  21. DeLand, Florida
  22. Delray Beach, Florida
  23. Delray Beach, Florida
  24. Jacksonville, Florida
  25. Longwood, Florida
  26. Longwood, Florida
  27. Miami, Florida
  28. Orlando, Florida
  29. Palm Harbor, Florida
  30. Pinellas Park, Florida
  31. Port Orange, Florida
  32. Port Orange, Florida
  33. Saint Petersburg, Florida
  34. West Palm Beach, Florida
  35. Atlanta, Georgia
  36. Atlanta, Georgia
  37. Fort Valley, Georgia
  38. Gainesville, Georgia
  39. Marietta, Georgia
  40. Woodstock, Georgia
  41. Woodstock, Georgia
  42. Boise, Idaho
  43. Springfield, Illinois
  44. Fishers, Indiana
  45. Valparaiso, Indiana
  46. Monroe, Louisiana
  47. Auburn, Maine
  48. Frederick, Maryland
  49. Wheaton, Maryland
  50. Mansfield, Massachusetts
  51. Worcester, Massachusetts
  52. Ann Arbor, Michigan
  53. Kalamazoo, Michigan
  54. Edina, Minnesota
  55. Edina, Minnesota
  56. Saint Louis, Missouri
  57. Omaha, Nebraska
  58. Las Vegas, Nevada
  59. Las Vegas, Nevada
  60. Las Vegas, Nevada
  61. Berlin, New Jersey
  62. Albuquerque, New Mexico
  63. Albuquerque, New Mexico
  64. Brooklyn, New York
  65. New York, New York
  66. Plainview, New York
  67. Roslyn, New York
  68. Charlotte, North Carolina
  69. Greensboro, North Carolina
  70. Winston-Salem, North Carolina
  71. Cincinnati, Ohio
  72. Cincinnati, Ohio
  73. Middleburg Heights, Ohio
  74. Zanesville, Ohio
  75. Oklahoma City, Oklahoma
  76. Beaverton, Oregon
  77. Portland, Oregon
  78. Portland, Oregon
  79. Bethlehem, Pennsylvania
  80. Downingtown, Pennsylvania
  81. Duncansville, Pennsylvania
  82. Rapid City, South Dakota
  83. Johnson City, Tennessee
  84. Kingsport, Tennessee
  85. Austin, Texas
  86. Austin, Texas
  87. Dallas, Texas
  88. Houston, Texas
  89. Houston, Texas
  90. Houston, Texas
  91. Plano, Texas
  92. San Antonio, Texas
  93. San Antonio, Texas
  94. San Antonio, Texas
  95. Spring, Texas
  96. Salt Lake City, Utah
  97. Charlottesville, Virginia
  98. Tacoma, Washington
  99. Yakima, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Tanezumab in Osteoarthritis Of The Hip
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 HIP.
Brief Summary The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip 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
  • Osteoarthritis, Hip
Intervention  ICMJE
  • Biological: tanezumab
    Tanezumab 10 mg IV every 8 weeks
  • Biological: tanezumab
    Tanezumab 5mg IV every 8 weeks
  • Biological: tanezumab
    Tanezumab 2.5 mg IV every 8 weeks.
  • Biological: Placebo
    Placebo to match tanezumab IV every 8 weeks
Study Arms  ICMJE
  • Experimental: Tanezumab 10 mg
    Tanezumab 10 mg IV every 8 weeks
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 5 mg
    Tanezumab 5mg IV every 8 weeks
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 2.5 mg
    Tanezumab 2.5 mg IV every 8 weeks.
    Intervention: Biological: tanezumab
  • Experimental: Placebo
    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: June 18, 2010)
627
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2008)
600
Actual Study Completion Date  ICMJE August 13, 2010
Actual Primary Completion Date March 15, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement 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
  • 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 NCT00744471
Other Study ID Numbers  ICMJE A4091014
P3 OA HIP ( 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