Trial Information

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Study Medicine On Peripheral Nerve Function In Patients With Osteoarthritis

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Study Medicine On Peripheral Nerve Function In Patients With Osteoarthritis

Patient Inclusion Criteria:

BMI less or equal to 39 kg/m2
Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies

Patient Exclusion Criteria:

Untreated, uncontrolled diseases,
Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
Significant cardiac disease within the past 6 months
Significant neurological disease
Known bleeding disorder or anticoagulation therapy
Planned surgery during the study period
History of alcoholism or drug abuse in the past 2 years
Unable to use acetaminophen
Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
Allergic reaction to a biologic or an antibody in the past
Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.

Suzi DeFiesta, Research Administrator
CSI Research Inc
11379 Southbridge Parkway, Suite B
Alpharetta, GA 30022
Phone: 770-667-0220
Fax: 770-667-0227
Email: sdefiesta@csi-research.com

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Research Center Information: CSI Research Inc

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