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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394563
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : October 12, 2009
Information provided by:

October 30, 2006
November 1, 2006
October 12, 2009
March 2006
October 2007   (Final data collection date for primary outcome measure)
Walking knee pain scores [ Time Frame: Day 112 ]
  • 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 Archive Site
  • Overall knee pain scores [ Time Frame: Day 112 ]
  • Incidence of adverse events and serious adverse events [ Time Frame: Day 112 ]
  • WOMAC [ Time Frame: Day 112 ]
  • 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
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • 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. doi: 10.1056/NEJMoa0901510. Epub 2010 Sep 29.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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

Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Not Provided
Study Director: Pfizer Call Center Pfizer
October 2009

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