A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered
by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective
of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to
placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the
long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the
treatment of chronic low back pain. In addition, the study will evaluate the effectiveness
and long term safety profile of tanezumab treatment for chronic low back pain compared to
tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic
low back pain.