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

The study will consist of a screening period of approximately 7 to 14 days (visit 1), an
open-label titration period of up to 6 weeks (visit 2 [titration baseline] through visit 6),
a double-blind treatment period of up to 12 weeks (visit 7 [day 0/baseline]; visits 8
through 11 [weeks 1, 2, 4, and 8, respectively; a final on-treatment visit [if applicable);
and a final study visit (visit 12/week 12 [or early termination]).

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.