NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain

Launched by ORTHO-MCNEIL JANSSEN SCIENTIFIC AFFAIRS, LLC · Sep 25, 2009

Keywords

ClinConnect Summary

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, ...

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ALL

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