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Tanezumab in Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00733902
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : January 7, 2011
Information provided by:

Brief Summary:
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.

Condition or disease Intervention/treatment Phase
Arthritis Osteoarthritis Biological: tanezumab Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 697 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double Blind, Placebo-Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee
Study Start Date : September 2008
Primary Completion Date : September 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tanezumab 10 mg Biological: tanezumab
IV tanezumab 10 mg at 1 dose every 8 weeks
Experimental: Tanezumab 5 mg Biological: tanezumab
IV tanezumab 5 mg at 1 dose every 8 weeks
Experimental: Tanezumab 2.5 mg Biological: tanezumab
IV tanezumab 2.5 mg at 1 dose every 8 weeks
Placebo Comparator: Placebo Biological: Placebo
IV placebo to match tanezumab at 1 dose every 8 weeks

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

Secondary Outcome Measures :
  1. Womac pain, physical function and stiffness at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ]
  2. SF-36 [ Time Frame: Weeks 12 and 24 ]
  3. Daily NRS scores [ Time Frame: daily to Week 32 ]
  4. Safety (AEs, laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ]
  5. Time to discontinuation [ Time Frame: All weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Osteoarthritis of the knee according to ACR criteria with a 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 knee injections arthroplasty or replace 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 or intent to become pregnant during the study
  • BMI greater than 39
  • other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

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 ClinicalTrials.gov identifier (NCT number): NCT00733902

  Show 65 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00733902     History of Changes
Other Study ID Numbers: A4091011
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: January 2011

Keywords provided by Pfizer:
monoclonal antibody
nerve growth factor
anti-nerve growth factor

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases