Tanezumab in Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00733902
First received: August 11, 2008
Last updated: January 4, 2011
Last verified: January 2011

August 11, 2008
January 4, 2011
September 2008
September 2009   (final data collection date for primary outcome measure)
  • WOMAC function [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • WOMAC pain [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • WOMAC function [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • WOMAC pain [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00733902 on ClinicalTrials.gov Archive Site
  • Womac pain, physical function and stiffness at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Daily NRS scores [ Time Frame: daily to Week 32 ] [ Designated as safety issue: No ]
  • Safety (AEs, laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
  • Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Daily NRS scores [ Time Frame: daily to Week 32 ] [ Designated as safety issue: No ]
  • Safety (laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
  • Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]
  • Womac pain, physical function and stiffnes at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tanezumab in Osteoarthritis of the Knee
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

Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Arthritis
  • Osteoarthritis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
697
November 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00733902
A4091011
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

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