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Tanezumab In Osteoarthritis Of The Hip Or Knee

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985621
First Posted: September 28, 2009
Last Update Posted: August 30, 2012
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

Condition Intervention Phase
Osteoarthritis Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: oxycodone Other: placebo Phase 3

Study Type: Interventional
Study Design: 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 Oxycodone-Controlled, Multicenter Study Of The Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • WOMAC pain [ Time Frame: Week 8 ]

Secondary Outcome Measures:
  • WOMAC Pain [ Time Frame: Weeks 2, 4, 12 and 16 ]
  • WOMAC Physical Function [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  • OMERACT OARSI responder index [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  • Reduction in the WOMAC Pain subscale of greater than or equal to 30/50/70/90% [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  • Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score [ Time Frame: Week 16 ]
  • Improvement of ≥2 points in Patient Global Assessment of Osteoarthritis [ Time Frame: Week 2, 4, 8, 12, and 16 ]
  • Average daily NRS pain score in the index knee or index hip change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  • WOMAC Stiffness subscale change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  • WOMAC Average change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
  • SF-36 [ Time Frame: Week 12 ]
  • EQ-5D [ Time Frame: Week 12 ]
  • Safety (AEs, laboratory, ECGs, PEs, vital signs, neurological exam) [ Time Frame: All Weeks ]

Enrollment: 600
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: oxycodone
oxycodone CR, 10-40 mg q12h
Placebo Comparator: 4 Other: placebo
placebo

Detailed Description:
This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • osteoarthritis of the knee or hip 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
  Contacts and Locations
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): NCT00985621


  Show 99 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00985621     History of Changes
Other Study ID Numbers: A4091030
First Submitted: September 25, 2009
First Posted: September 28, 2009
Last Update Posted: August 30, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents