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A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00394563
First received: October 30, 2006
Last updated: October 7, 2009
Last verified: October 2009

October 30, 2006
October 7, 2009
March 2006
October 2007   (final data collection date for primary outcome measure)
Walking knee pain scores [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
  • Daily walking knee pain scores up to Day 112
  • Subject global assessment up to Day 112
Complete list of historical versions of study NCT00394563 on ClinicalTrials.gov Archive Site
  • Overall knee pain scores [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
  • Incidence of adverse events and serious adverse events [ Time Frame: Day 112 ] [ Designated as safety issue: Yes ]
  • WOMAC [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
  • Daily overall knee pain scores up to Day 112
  • Incidence of adverse events, serious adverse events and death
  • WOMAC subscales and average
Not Provided
Not Provided
 
A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain
A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety and Efficacy of RN624 in Adults With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee

The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis
  • Drug: RN624 (PF-04383119)
    10 mcg/kg
  • Drug: RN624 (PF-04383119)
    25 mcg/kg
  • Drug: RN624 (PF-04383119)
    50 mcg/kg
  • Drug: RN624 (PF-04383119)
    100 mcg/kg
  • Drug: RN624 (PF-04383119)
    200 mcg/kg
  • Drug: placebo
  • Experimental: 1
    monoclonal antibody
    Intervention: Drug: RN624 (PF-04383119)
  • Experimental: 2
    Intervention: Drug: RN624 (PF-04383119)
  • Experimental: 3
    Intervention: Drug: RN624 (PF-04383119)
  • Experimental: 4
    Intervention: Drug: RN624 (PF-04383119)
  • Experimental: 5
    Intervention: Drug: RN624 (PF-04383119)
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Lane NE, Schnitzer TJ, Birbara CA, Mokhtarani M, Shelton DL, Smith MD, Brown MT. Tanezumab for the treatment of pain from osteoarthritis of the knee. N Engl J Med. 2010 Oct 14;363(16):1521-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain).

Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery

Exclusion Criteria:

History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders

Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00394563
A4091008, RN624-CL006
Yes
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

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