Tanezumab In Osteoarthritis Of The Hip Or Knee

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”

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

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.

Intervention(s) in this Clinical Trial

• Biological: tanezumab 10 mg
  • tanezumab 10 mg one dose at weeks 0 and 8
• Biological: tanezumab 5 mg
  • tanezumab 5 mg one dose at weeks 0 and 8
• Drug: oxycodone
  • oxycodone CR, 10-40 mg q12h
• Other: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3
• Placebo Comparator: 4

Primary Measures

• WOMAC pain
  • Time Frame: Week 8
    Safety Issue?: No

Secondary Measures

• WOMAC Pain
  • Time Frame: Weeks 2, 4, 12 and 16
    Safety Issue?: No
• WOMAC Physical Function
  • Time Frame: Weeks 2, 4, 8, 12, and 16
    Safety Issue?: No
• Patient Global Assessment of Osteoarthritis
  • Time Frame: Weeks 2, 4, 8, 12, and 16
    Safety Issue?: No
• OMERACT OARSI responder index
  • Time Frame: Weeks 2, 4, 8, 12, and 16
    Safety Issue?: No
• 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
    Safety Issue?: No
• Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score
  • Time Frame: Week 16
    Safety Issue?: No
• Improvement of ≥2 points in Patient Global Assessment of Osteoarthritis
  • Time Frame: Week 2, 4, 8, 12, and 16
    Safety Issue?: No
• Average daily NRS pain score in the index knee or index hip change from Baseline
  • Time Frame: Weeks 2, 4, 8, 12, and 16
    Safety Issue?: No
• WOMAC Stiffness subscale change from Baseline
  • Time Frame: Weeks 2, 4, 8, 12, and 16
    Safety Issue?: No
• WOMAC Average change from Baseline
  • Time Frame: Weeks 2, 4, 8, 12, and 16
    Safety Issue?: No
• SF-36
  • Time Frame: Week 12
    Safety Issue?: No
• EQ-5D
  • Time Frame: Week 12
    Safety Issue?: No
• Safety (AEs, laboratory, ECGs, PEs, vital signs, neurological exam)
  • Time Frame: All Weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00985621

Study ID Number: A4091030

ClinicalTrials.gov Identifier: NCT00985621

Health Authority: United States: Food and Drug Administration

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