Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

Inclusion Criteria: * The patient has had moderate to severe chronic low back pain for at least 3 months duration before screening. * The patient is able to speak English and is willing to provide written informed consent, including a written opioid agreement, to participate in this study. * The patient is willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the study center for scheduled study visits, as specified in the protocol. * The patient is 18 through 80 years of age at the time of screening. * Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception, agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening. - Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. NOTE: A woman will be considered surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy. * Other criteria apply. Exclusion Criteria: * The patient is taking a total of more than 135 mg/day of oxycodone, or equivalent, during the 14 days before screening. * The patient's primary painful condition under study is related to any source of chronic pain other than low back pain. * The patient has radicular (nerve compression) pain or another type of purely neuropathic pain. * The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug. * The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse, with the exception of nicotine. * The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. * Other criteria apply.