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A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections - NCT00994890-73112(Clinical Trial 443167)



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City:  Oklahoma
State:  
OK
Zip Code: 73112
Conditions: Osteoarthritis, Knee - Osteoarthritis, Hip
Purpose: This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.
Study summary: Safety study of tanezumab in relief of osteoarthritis pain
Criteria: Inclusion Criteria: - Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2); Exclusion Criteria: - Body mass index (BMI) of >39 kg/m2; - Pregnancy or intent to become pregnant - Planned surgical procedure during the duration of the study - History of clinically significant cardiovascular, central nervous system or psychiatric disease - Previous exposure to exogenous NGF or to an anti NGF antibody; - Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions
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Data Source: ClinicalTrials.gov
Date Processed: July 2, 2010
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