A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
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 effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the
 knee by itself or with naproxen, particularly to test if patients have less pain.
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 alter the potential benefit - risk profile of the study medication.
Inclusion Criteria:

 -  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 Criteria:

 -  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