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Tanezumab in Osteoarthritis of the Hip or Knee (2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00863304
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : May 5, 2011
Information provided by:

Brief Summary:
Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: naproxen Other: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 849 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Study of Tanezumab in Patients With Osteoarthritis Of The Hip or Knee
Study Start Date : May 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Naproxen

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. WOMAC function [ Time Frame: weeks 12 and 16 ]
  2. WOMAC pain [ Time Frame: weeks 12 and 16 ]
  3. Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 12 and 16 ]

Secondary Outcome Measures :
  1. Womac physical function [ Time Frame: weeks 2, 4, 8, 12 and 16 ]
  2. Womac pain [ Time Frame: weeks 2, 4, 8, 12 and 16 ]
  3. Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 2, 4, 8, 12 and 16 ]
  4. OMERACT-OARSI responder criteria [ Time Frame: weeks 2, 4, 8, 12 and 16 ]
  5. SF-36 [ Time Frame: weeks 12 and 16 ]
  6. Daily NRS scores [ Time Frame: weeks 2, 4, 8, 12 and 16 ]
  7. Safety (AEs, laboratory, ECGs, PEs, vital signs) [ Time Frame: all weeks ]
  8. Time to discontinuation [ Time Frame: all weeks ]
  9. Womac stiffness [ Time Frame: weeks 2, 4, 8, 12 and 16 ]
  10. Treatment Response: Reduction in WOMAC Pain Subscale [ Time Frame: weeks 2, 4, 8, 12 and 16 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Osteoarthritis of the hip or 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, neurological or psychiatric disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00863304

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00863304    
Other Study ID Numbers: A4091018
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: May 5, 2011
Last Verified: May 2011
Keywords provided by Pfizer:
monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action