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Tanezumab in Osteoarthritis Of The Hip

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.
ClinicalTrials.gov Identifier: NCT00744471
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : April 29, 2011
Information provided by:

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 627 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 Hip
Study Start Date : November 2008
Primary Completion Date : March 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tanezumab 10 mg
Tanezumab 10 mg IV every 8 weeks
Biological: tanezumab
Tanezumab 10 mg IV every 8 weeks
Experimental: Tanezumab 5 mg
Tanezumab 5mg IV every 8 weeks
Biological: tanezumab
Tanezumab 5mg IV every 8 weeks
Experimental: Tanezumab 2.5 mg
Tanezumab 2.5 mg IV every 8 weeks.
Biological: tanezumab
Tanezumab 2.5 mg IV every 8 weeks.
Experimental: Placebo
Biological: Placebo
Placebo to match tanezumab IV every 8 weeks

Primary Outcome Measures :
  1. Womac Pain [ Time Frame: Week 16 ]
  2. Patient Global Assessment of Arthritis [ Time Frame: Week 16 ]
  3. Womac Function [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Womac pain, physical function and stiffness; Patient Global Assessment of Arthritis [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  2. Sf-36 [ Time Frame: Weeks 12 and 24 ]
  3. Safety (laboratory, ECGs, vitals) [ Time Frame: all weeks ]
  4. Time to discontinuations [ Time Frame: all weeks ]
  5. Daily NRS scores [ Time Frame: daily to Week 24 ]

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 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

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): NCT00744471

  Show 88 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: NCT00744471     History of Changes
Other Study ID Numbers: A4091014
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: April 2011

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

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