NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the
 treatment of acute low back pain.
This is a randomized, outpatient, multicenter, double-blind study (blinded to patient and to
 study doctor) comparing NUCYNTA to oxycodone IR in the treatment of patients with acute (new
 onset) low back pain who also have associated leg pain that radiates (travels down) below the
 knee. Patients will be screened for study eligibility at Visit 1. The study will be explained
 and informed consent will be obtained. Potential patients must satisfy all eligibility
 criteria to be enrolled in the study. Eligible candidates will proceed to the Double-Blind
 Treatment Phase. At the time of study entry, all prohibited medications will be discontinued
 and will be disallowed throughout the study. All patients will call into an interactive voice
 response system (IVRS) to complete a pain assessments twice daily throughout the study.
 Patients who discontinue early for any reason will be instructed to contact the study site to
 complete final assessments, prior to taking supplemental pain medication if applicable, and
 to schedule a final study visit. All patients will return to the study site on Day 5 (Visit
 2) where they will be evaluated by study personnel and, as appropriate, continue with study
 treatment for an additional 5 days. Patients will return to the study site for the final
 visit on Day 10/End of Study (Visit 3) when they will have all final study assessments. The
 treatment duration will be up to 10 days. The sponsor will collect adverse events starting
 with the signing of the informed consent form. Adverse events will be reported by the subject
 for the duration of the study. Any clinically significant abnormalities persisting at the end
 of the study will be followed by the investigator until resolution or until a clinically
 stable endpoint is reached. Blood samples for serum chemistry and hematology and a urine
 sample for urinalysis will be collected. The investigator will review the laboratory report,
 document this review, and record any clinically relevant changes occurring during the study.
 The following tests will be performed by the central laboratory: Urine Pregnancy Testing for
 women of childbearing potential only, Urine Drug Screen, Vital Signs (pulse rate and blood
 pressure), Physical Examination, Neurological Examination, and Vomiting Assessment. The study
 will be conducted at approximately 80 sites in the United States (US). Patients will be
 randomized to one of the two following treatment groups: NUCYNTA 50, 75 or 100 mg every 4 to
 6 hours up to 10 days as needed for pain. Oxycodone IR 5, 10 or 15 mg every 4 to 6 hours as
 needed for pain. Patients will begin treatment on Day 1 with one "lower dose" capsule of
 study drug (NUCYNTA 50 mg or oxycodone IR 5 mg). Subsequent dose adjustments will be made by
 study patients, as needed, to achieve a dose that provides a meaningful improvement in their
 pain intensity
Inclusion Criteria:

 -  At Visit 1 (study entry) patients must have a medical history and physical and
 neurological examinations that support a clinical diagnosis of acute low back pain
 that is felt down to the lower leg below the knee with the onset no longer than 30
 days before Visit 1

 -  At Visit 1 patients must report qualifying pain intensity scores

 -  Patients must be appropriate candidates for treatment with oral opioid pain medication
 in the investigator's clinical judgment

 -  Patients must be able to appropriately verbalize pain characteristics and to complete
 all protocol required measurements/assessments without assistance

 -  Patients must be medically stable on the basis of physical examination, medical
 history, vital signs, and clinical laboratory tests performed at screening

 Exclusion Criteria:

 -  History of back (cervical, thoracic or lumbosacral) pain =50% of the time in the 1
 year prior to the first visit

 -  History of any low back pain episode, with the exception of the current acute low back
 pain episode, within 3 months prior to the first visit that was greater than mild in
 pain intensity, or was associated with disability (e.g., loss of time from work,
 family, or activities of daily living), or necessitated the use of an opioid
 (narcotic) analgesic including tramadol

 -  Medical history or physical examination results that suggest the acute low back pain
 or any of the neurological symptoms or signs are caused by a serious medical condition
 (e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or
 incontinence, bilateral leg weakness, progressive weakness, paralysis)

 -  There is a high probability for surgical intervention for the back pain during the
 projected time on the study or that there will be an increase in the severity of the
 leg pain or deficits

 -  Had either a surgical procedure involving the spine or intervertebral discs in the
 lower back region within 1 year prior to Visit 1 or had >1 surgical procedure(s)
 involving the spine or intervertebral discs in the lower back region

 -  has any painful condition that could interfere with the study assessments or with the
 patient's ability to differentiate the pain associated with the acute low back pain
 episode from pain associated with another condition

 -  History of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis

 -  history of epilepsy or recurrent seizures

 -  Unable or unwilling to discontinue all prohibited medications at the time of
 randomization and during the time of their participation in the study

 -  Known or suspected history of alcohol or drug abuse based on medical history, physical
 examination, urine drug screening, or the investigator's clinical judgment

 -  History of cancer malignancy within 2 years prior to the first visit, with the
 exception of basal cell skin carcinoma

 -  Have filed or plan to file a worker's compensation claim for any issue related to the
 current acute low back pain episode

 -  Currently involved in litigation or plan to seek legal recourse for any issue related
 to their acute low back pain

 -  Known allergies, hypersensitivity, or intolerance to tapentadol or the comparator
 (oxycodone) or any excipients used in their manufacture

 -  Had previously been enrolled in a tapentadol clinical study

 -  is pregnant or are breast-feeding