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Tanezumab in Osteoarthritis Of The Hip

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 29, 2008
Last updated: April 25, 2011
Last verified: April 2011
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 Intervention Phase
Arthritis Osteoarthritis Osteoarthritis, Hip Biological: tanezumab Biological: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Womac Pain [ Time Frame: Week 16 ]
  • Patient Global Assessment of Arthritis [ Time Frame: Week 16 ]
  • Womac Function [ Time Frame: Week 16 ]

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

Enrollment: 627
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  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 identifier: NCT00744471

  Show 88 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00744471     History of Changes
Other Study ID Numbers: A4091014
Study First Received: August 29, 2008
Last Updated: April 25, 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 processed this record on September 21, 2017