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 is a randomized, double blind, placebo and active controlled, multicenter, parallel
group Phase 3 study of the efficacy and safety of tanezumab when administered by SC
injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800
subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects
per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and
600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo
administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At
the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be
switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg
administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56;
2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to
Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching
tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week
interval to Week 56. The study is designed with a total duration (post randomization) of up
to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days;
includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment
Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and
Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37
days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and
an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to
entering the study, subjects must have a documented history of previous inadequate treatment
response to medications in 3 different categories of agents commonly used to treat and
generally considered effective for the treatment of chronic low back pain.
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