Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Osteoarthritis

Eligibility:

All Genders

40-75 years

Phase:

PHASE2

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 p...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

450 Patients enrolled

Trial Details

Trial ID

NCT00394563

Start Date

March 1 2006

End Date

October 1 2007

Last Update

October 12 2009

Active Locations (48)

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Page 1 of 12 (48 locations)

1

Pfizer Investigational Site

Birmingham, Alabama, United States, 35209

2

Pfizer Investigational Site

Phoenix, Arizona, United States, 85013

3

Pfizer Investigational Site

Phoenix, Arizona, United States, 85023

4

Pfizer Investigational Site

Tucson, Arizona, United States, 85712