An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)

This is a multi-center, single group, open-label (all people know the identity of the
intervention) treatment study to describe the overall clinical experience in participants
with moderate to severe chronic low back pain or OA pain of the hip or knee, after conversion
from hydrocodone, oxycodone CR, and/or morphine SR, using dose-conversion ratios of 1:5, 1:5
and 1:2.5, respectively.

Approximately 150 participants taking hydrocodone, oxycodone CR, and/or morphine SR with
baseline pain intensity ≥4 (ie, pain intensity scores averaged over the last 4 days of the
screening period on an 11-point numeric rating scale [NRS]) will be converted to an initial
dose of tapentadol ER 100, 150 or 200 mg approximately every 12 hours based on their total
daily dose of prior opioids. Enrollment of participants in any prior opioid group
(hydrocodone, oxycodone CR, and/or morphine SR) may be stopped at any time during the study
to ensure adequate representation of each prior opioid.

The study will consist of two periods: screening (1 Week) and treatment (4 weeks). The
expected duration of participation for individual participants is approximately 5 weeks,
including 4 weeks of active study treatment. The study will include scheduled visits and may
also include unscheduled phone calls and site visits for dose adjustment and/or for safety
evaluations.

Inclusion Criteria:

- Have a clinical diagnosis of knee or hip osteoarthritis (OA) with history of pain at
the reference joint or clinical diagnosis of low back pain (LBP) of non malignant
origin for at least 3 months before the screening visit; Be taking hydrocodone,
oxycodone CR, or morphine SR for the treatment of chronic LBP, or OA of the knee or
hip for at least 2 weeks before the screening visit; Have a baseline pain intensity
score of ≥4 on an 11-point pain intensity numeric rating scale; Be willing and able to
independently communicate pain characteristics, complete all protocol required
measurements/assessments without assistance, understand and complete self-administered
questionnaires and adhere to the prohibitions and restrictions specified in this
protocol.

Exclusion Criteria:

- Had surgery in the low back area or the reference joint within 3 months before the
screening visit, or will not have fully recovered from surgery by the screening visit,
or is expected to require surgical intervention in the low back area or the reference
joint during participation in the study; For participants with OA of the hip or knee,
has a clinical history and findings at the reference joint suggesting the pain is
secondary to crystal-induced, metabolic, infectious, and/or autoimmune disease(s); Has
a known history of severe chronic renal insufficiency, severely impaired hepatic
function, or alanine aminotransferase or aspartate aminotransferase greater than three
times the upper limit of normal; Has a history of seizure disorder, epilepsy, or
recurrent seizures; Has any of the following within 1 year before the screening visit:
mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain
neoplasm; Has a known or suspected history of alcohol abuse in the past 10 years or
any history of drug abuse; Has a history of malignancy within 2 years before the
screening visit, with the exception of basal cell carcinoma that has been successfully
treated; Has significant respiratory depression, acute or severe bronchial asthma, or
hypercapnia and paralytic ileus; Has a known history of allergies, hypersensitivity,
or contraindication to tapentadol, hydrocodone, morphine, oxycodone, or acetaminophen
or their excipients; In a participant taking oxycodone CR or morphine SR at screening,
is also taking more than 2 doses per day of an IR opioid for breakthrough pain
(exclusion does not apply if prior opioid is hydrocodone); Is taking daily
acetaminophen at a dose that exceeds 3,000 mg/day, including both acetaminophen and
acetaminophen-containing combination products; Has received systemic corticosteroids
within 4 weeks before the screening visit; For participant with OA, has received an
injection of hyaluronic acid into the reference joint within 4 weeks before the
screening visit; Has taken a monoamine oxidase inhibitor within 14 days before the
screening visit; Has received an investigational drug or used an invasive
investigational medical device within 30 days before the screening visit or is
currently enrolled in an investigational study; Has previously participated in this
clinical study; Is a woman who is pregnant, breast-feeding, or planning to become
pregnant within 2 weeks after the last dose of study drug; Has any planned procedure
that would require supplemental analgesics during the time of expected participation
in the study; Has any significant pain condition other than chronic LBP or OA that, in
the opinion of the investigator, could confound the assessment or self-evaluation of
pain; Current diagnosis of fibromyalgia, complex regional pain syndrome, acute spinal
cord compression, bowel or bladder dysfunction as a result of cauda equina
compression, back pain caused by secondary infection, or pain caused by suspected
neoplasm; Have answered "yes" to items 1 and 2 in the Columbia Suicide Severity Rating
Scale administered at the screening visit.