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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2010

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 16
    Safety Issue?: No

Secondary Measures

• WOMAC Pain
  • Time Frame: Weeks 2, 4, 8 and 12
    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% and greater than or equal to 50%
  • 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 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: Weeks 2, 4, 8, 12, and 16
    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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on February 08, 2010

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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