Clinical trial NCT00394563: A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: osteoarthritis monoclonal antibody
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-01
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Walking knee pain scores
timeFrame: Day 112
Secondary outcomes:
measure: Overall knee pain scores
timeFrame: Day 112
measure: Incidence of adverse events and serious adverse events
timeFrame: Day 112
measure: WOMAC
timeFrame: Day 112
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Cypress
country: United States
facility: Pfizer Investigational Site
state: California
city: National City
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacremento
country: United States
facility: Pfizer Investigational Site
state: California
city: Stamford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: North Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Merrillville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Reno
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Zanesville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bethlehem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Midvale
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Yakima
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.