- Male or female of any race, >18 years of age and have BMI ≤39 kg/m2
- Present with duration of chronic low back pain of ≥3 months requiring regular use of
analgesic medication (>4 days per week for the past month)
- Primary location of low back pain is between the 12th thoracic vertebra and the lower
gluteal folds, with or without radiation into the posterior thigh, classified as
Category 1 or 2 according to the classification of the Quebec Task Force in Spinal
Disorders
- Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment
at Screening, and completes at least 4 daily pain diaries during the 5 days prior to
Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4
- Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent
major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)
- History of lumbosacral radiculopathy, spinal stenosis associated with neurological
impairment, or neurogenic claudication
- Osteoporotic compression fracture within the last 6 months
- Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e.,
ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel
disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia;
Tumors or infections of the spinal cord
- Patients receiving acetaminophen only to manage their chronic low back pain
- Any uncontrolled or untreated chronic disease