Tanezumab In Osteoarthritis Of The Knee (2)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00830063
First received: January 23, 2009
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Arthritis
Osteoarthritis
Biological: tanezumab 10 mg
Biological: tanezumab 5 mg
Drug: naproxen
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • WOMAC function [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
  • WOMAC pain [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Womac physical function [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Womac pain [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • OMERACT-OARSI responder criteria [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
  • Daily NRS scores [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Safety (AEs, laboratory, ECGs, PEs, vital signs) [ Time Frame: all weeks ] [ Designated as safety issue: Yes ]
  • Time to discontinuation [ Time Frame: all weeks ] [ Designated as safety issue: No ]
  • Womac stiffness [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Treatment Response: Reduction in the WOMAC Pain subscale [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]

Enrollment: 848
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: tanezumab 10 mg
tanezumab 10 mg one dose at weeks 0 and 8
Experimental: 2 Biological: tanezumab 5 mg
tanezumab 5 mg one dose at weeks 0 and 8
Active Comparator: 3 Drug: naproxen
naproxen 1000 mg daily for 16 weeks
Placebo Comparator: 4 Other: placebo
placebo to match tanezumab and naproxen dosing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830063

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Locations
United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
United States, Arizona
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Mesa, Arizona, United States, 85203
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Paradise Valley, Arizona, United States, 85253
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85023
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Phoenix, Arizona, United States, 85037
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Tempe, Arizona, United States, 85282
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Tucson, Arizona, United States, 85724
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Tuscon, Arizona, United States, 85724
United States, Arkansas
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Hot Springs, Arkansas, United States, 71913
United States, California
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Beverly Hills, California, United States, 90211
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Fresno, California, United States, 93720
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Huntington Beach, California, United States, 92646
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Sacramento, California, United States, 95817
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Thousand Oaks, California, United States, 91360
United States, Connecticut
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Stamford, Connecticut, United States, 06905
United States, Delaware
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Newark, Delaware, United States, 19713
United States, Florida
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Clearwater, Florida, United States, 33756
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Clearwater, Florida, United States, 33761
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Coral Gables, Florida, United States, 33134
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DeLand, Florida, United States, 32720
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Jacksonville, Florida, United States, 32205
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Longwood, Florida, United States, 32779
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Miami, Florida, United States, 33175
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Palm Harbor, Florida, United States, 34684
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Pembroke Pines, Florida, United States, 33024
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Port Orange, Florida, United States, 32127
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Tamarac, Florida, United States, 33321
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West Palm Beach, Florida, United States, 33409
United States, Georgia
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Atlanta, Georgia, United States, 30342
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Decatur, Georgia, United States, 30033
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Marietta, Georgia, United States, 30060
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Woodstock, Georgia, United States, 30188
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Woodstock, Georgia, United States, 30189
United States, Idaho
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Boise, Idaho, United States, 83702
United States, Illinois
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Chicago, Illinois, United States, 60611-4542
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Chicago, Illinois, United States, 60611
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Morton, Illinois, United States, 61550
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Morton Grove, Illinois, United States, 60053
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Springfield, Illinois, United States, 62704
United States, Indiana
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Valparaiso, Indiana, United States, 46383
United States, Iowa
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Ames, Iowa, United States, 50010
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West Des Moines, Iowa, United States, 50265
United States, Kansas
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Wichita, Kansas, United States, 67203
United States, Kentucky
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Louisville, Kentucky, United States, 40202
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70816
United States, Maine
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Auburn, Maine, United States, 04210
United States, Maryland
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Frederick, Maryland, United States, 21702
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Wheaton, Maryland, United States, 20902
United States, Massachusetts
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Worcester, Massachusetts, United States, 01610
United States, Michigan
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St. Clair Shores, Michigan, United States, 48081
United States, Minnesota
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Edina, Minnesota, United States, 55435
United States, Missouri
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St. Louis, Missouri, United States, 63141
United States, Nebraska
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Omaha, Nebraska, United States, 68114
United States, Nevada
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Las Vegas, Nevada, United States, 89128
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Las Vegas,, Nevada, United States, 89119
United States, New Jersey
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Berlin, New Jersey, United States, 08009
United States, New Mexico
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Albuquerque, New Mexico, United States, 87106
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Albuquerque, New Mexico, United States, 87102
United States, New York
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New York, New York, United States, 10024
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Rochester, New York, United States, 14618
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Roslyn, New York, United States, 11576
United States, North Carolina
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Charlotte, North Carolina, United States, 28210
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Greensboro, North Carolina, United States, 27408
United States, North Dakota
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Fargo, North Dakota, United States, 58104
United States, Ohio
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Cincinnati, Ohio, United States, 45224
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Middleburg Heights, Ohio, United States, 44130
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Zanesville, Ohio, United States, 43701
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
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West Reading, Pennsylvania, United States, 19611-1124
United States, South Carolina
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Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
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Rapid City, South Dakota, United States, 57702
United States, Tennessee
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Johnson City, Tennessee, United States, 37604-1417
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Kingsport, Tennessee, United States, 37660
United States, Texas
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Austin, Texas, United States, 78705
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Dallas, Texas, United States, 75230
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Houston, Texas, United States, 77008
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Houston, Texas, United States, 77036
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78217
United States, Utah
Pfizer Investigational Site
Orem, Utah, United States, 84058
United States, Virginia
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Norfolk, Virginia, United States, 23502
Pfizer Investigational Site
Portsmouth, Virginia, United States, 23701
United States, Washington
Pfizer Investigational Site
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00830063     History of Changes
Other Study ID Numbers: A4091015
Study First Received: January 23, 2009
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
monoclonal antibody
RN624
PF-04383119
nerve growth factor
anti-nerve growth factor
OA
pain

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014