NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
Condition: Pain; Back Pain; Low Back Pain; Back Pain With Radiation
MeSH terms: Back Pain; Low Back Pain
Intervention: NUCYNTA; Oxycodone IR
Intervention description: 50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain; 5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain
Intervention MeSH terms: Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 667.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Low Back Pain; Low Back Pain With Leg Pain Below The Knee; Radiculopathy, Oxycodone; Tapentadol; NUCYNTA

Summary:

      Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the
      treatment of acute low back pain.
    

Eligibility criteria:

        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