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Trial record 1 of 1 for:    NCT00733902
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Tanezumab in Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00733902
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : January 7, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 11, 2008
First Posted Date  ICMJE August 13, 2008
Last Update Posted Date January 7, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
  • WOMAC function [ Time Frame: Week 16 ]
  • WOMAC pain [ Time Frame: Week 16 ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Week 24 ]
  • WOMAC function [ Time Frame: Week 24 ]
  • WOMAC pain [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
  • Womac pain, physical function and stiffness at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ]
  • SF-36 [ Time Frame: Weeks 12 and 24 ]
  • Daily NRS scores [ Time Frame: daily to Week 32 ]
  • Safety (AEs, laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ]
  • Time to discontinuation [ Time Frame: All weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
  • SF-36 [ Time Frame: Weeks 12 and 24 ]
  • Daily NRS scores [ Time Frame: daily to Week 32 ]
  • Safety (laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ]
  • Time to discontinuation [ Time Frame: All weeks ]
  • Womac pain, physical function and stiffnes at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tanezumab in Osteoarthritis of the Knee
Official Title  ICMJE A Phase 3 Randomized, Double Blind, Placebo-Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee
Brief Summary Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Arthritis
  • Osteoarthritis
Intervention  ICMJE
  • Biological: tanezumab
    IV tanezumab 10 mg at 1 dose every 8 weeks
  • Biological: tanezumab
    IV tanezumab 5 mg at 1 dose every 8 weeks
  • Biological: tanezumab
    IV tanezumab 2.5 mg at 1 dose every 8 weeks
  • Biological: Placebo
    IV placebo to match tanezumab at 1 dose every 8 weeks
Study Arms  ICMJE
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 5 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 2.5 mg
    Intervention: Biological: tanezumab
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2009)
697
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2008)
600
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the knee according to ACR criteria with a 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 knee injections arthroplasty or replace 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 or intent to become pregnant during the study
  • BMI greater than 39
  • other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00733902
Other Study ID Numbers  ICMJE A4091011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP