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

NCT00394563

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2006)
450
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 75 Years   (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 NCT00394563
Other Study ID Numbers  ICMJE A4091008
RN624-CL006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

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