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Tanezumab In Osteoarthritis Of The 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: NCT00830063
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : June 21, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Arthritis 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 : 848 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 Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee
Study Start Date : May 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 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 the 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 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

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): NCT00830063

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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: NCT00830063    
Other Study ID Numbers: A4091015
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: June 2011
Keywords provided by Pfizer:
monoclonal antibody
nerve growth factor
anti-nerve growth factor
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Molecular Mechanisms of Pharmacological Action
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