Tanezumab in Osteoarthritis Of The Hip

NCT00744471

Last updated date
Study Location
Pfizer Investigational Site
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 + 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]

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. Peoria, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. TUcson, Arizona
  7. Hot Springs, Arkansas
  8. Burbank, California
  9. Escondido, California
  10. Huntington Beach, California
  11. Santa Ana, California
  12. Danbury, Connecticut
  13. Stamford, Connecticut
  14. Newark, Delaware
  15. Clearwater, Florida
  16. Clearwater, Florida
  17. DeLand, Florida
  18. Delray Beach, Florida
  19. Jacksonville, Florida
  20. Longwood, Florida
  21. Miami, Florida
  22. Orlando, Florida
  23. Palm Harbor, Florida
  24. Pinellas Park, Florida
  25. Port Orange, Florida
  26. Port Orange, Florida
  27. St Petersburg, Florida
  28. West Palm Beach, Florida
  29. Atlanta, Georgia
  30. Fort Valley, Georgia
  31. Gainesville, Georgia
  32. Woodstock, Georgia
  33. Boise, Idaho
  34. Springfield, Illinois
  35. Fishers, Indiana
  36. Valparaiso, Indiana
  37. Monroe, Louisiana
  38. Auburn, Maine
  39. Frederick, Maryland
  40. Wheaton, Maryland
  41. Mansfield, Massachusetts
  42. Worcester, Massachusetts
  43. Ann Arbor, Michigan
  44. Kalamazoo, Michigan
  45. Edina, Minnesota
  46. St. Louis, Missouri
  47. Omaha, Nebraska
  48. Las Vegas,, Nevada
  49. Las Vegas, Nevada
  50. Berlin, New Jersey
  51. Albuquerque, New Mexico
  52. Albuquerque, New Mexico
  53. Brooklyn, New York
  54. New York, New York
  55. Plainview, New York
  56. Roslyn, New York
  57. Charlotte, North Carolina
  58. Greensboro, North Carolina
  59. Winston-Salem, North Carolina
  60. Cincinnati, Ohio
  61. Cincinnati, Ohio
  62. Middleburg Heights, Ohio
  63. Zanesville, Ohio
  64. Oklahoma City, Oklahoma
  65. Beaverton, Oregon
  66. Portland, Oregon
  67. Portland, Oregon
  68. Bethlehem, Pennsylvania
  69. Downingtown, Pennsylvania
  70. Duncansville, Pennsylvania
  71. Rapid City, South Dakota
  72. Johnson City, Tennessee
  73. Kingsport, Tennessee
  74. Austim, Texas
  75. Austin, Texas
  76. Dallas, Texas
  77. Houston, Texas
  78. Houston, Texas
  79. Houston, Texas
  80. Plano, Texas
  81. San Antonio, Texas
  82. San Antonio, Texas
  83. Spring, Texas
  84. Salt Lake City, Utah
  85. Charlottesville, Virginia
  86. Tacoma, Washington
  87. Tacoma, Washington
  88. 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 June 2010
Actual Primary Completion Date March 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 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 NCT00744471
Other Study ID Numbers  ICMJE A4091014
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 April 2011

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