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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
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

NCT00394563
Pfizer
Completed
A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

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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
Intervention Model: Parallel Assignment
Masking: Double
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. 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.
 
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

Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00394563
A4091008
RN624-CL006
Yes
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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