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Tanezumab In Osteoarthritis Of The Knee (2)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00830063
First received: January 23, 2009
Last updated: June 7, 2011
Last verified: June 2011

January 23, 2009
June 7, 2011
May 2009
May 2010   (final data collection date for primary outcome measure)
  • WOMAC function [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
  • WOMAC pain [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830063 on ClinicalTrials.gov Archive Site
  • Womac physical function [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Womac pain [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • OMERACT-OARSI responder criteria [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
  • Daily NRS scores [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Safety (AEs, laboratory, ECGs, PEs, vital signs) [ Time Frame: all weeks ] [ Designated as safety issue: Yes ]
  • Time to discontinuation [ Time Frame: all weeks ] [ Designated as safety issue: No ]
  • Womac stiffness [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Treatment Response: Reduction in the WOMAC Pain subscale [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tanezumab In Osteoarthritis Of The Knee (2)
A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee

The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Arthritis
  • Osteoarthritis
  • 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: naproxen
    naproxen 1000 mg daily for 16 weeks
  • Other: placebo
    placebo to match tanezumab and naproxen dosing
  • Experimental: 1
    Intervention: Biological: tanezumab 10 mg
  • Experimental: 2
    Intervention: Biological: tanezumab 5 mg
  • Active Comparator: 3
    Intervention: Drug: naproxen
  • Placebo Comparator: 4
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
848
July 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Osteoarthritis of the knee 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, neurologic or cardiac disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00830063
A4091015
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

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