Status:
TERMINATED
A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effec...
Detailed Description
This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may ...
Eligibility Criteria
Inclusion
- Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray
- Subjects must be willing and able to stop all current pain therapy for the duration of the study
- Subjects must be willing and able to complete a daily diary
Exclusion
- BMI of \>39 kg/m2
- Known allergy or hypersensitivity to naproxen
- Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT01147458
Start Date
July 1 2010
End Date
February 1 2011
Last Update
June 6 2013
Active Locations (31)
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1
Pfizer Investigational Site
Peoria, Arizona, United States, 85381
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85015
4
Pfizer Investigational Site
Anaheim, California, United States, 92801