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

Official Title: “A Randomized, Double-Blind, Parallel-Group Study of NUCYNTA (Tapentadol) Immediate Release vs. Oxycodone Immediate Release for 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

Intervention(s) in this Clinical Trial

• Drug: NUCYNTA
  • 50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain
• Drug: Oxycodone IR
  • 5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001
  • NUCYNTA 50 75 or 100 mg every 4 to 6 hours for up to 10 days as needed for pain
• Active Comparator: 002
  • Oxycodone IR 5 10 or 15 mg every 4 to 6 hours for up to 10 days as needed for pain

Primary Measures

• The primary outcome measure is the sum of pain intensity difference at 72 hours from baseline as measured by an 11-point numeric rating scale (NRS).
  • Time Frame: Pain Intensity scores will be done at study entry, on Days 1 -10 by phone, and at the End of Study visit (doctor's office)
    Safety Issue?: No

Secondary Measures

• Assessment of pain relief (5-point NRS)
  • Time Frame: Days 1 through 10 and End of Study Visit
    Safety Issue?: No
• Assessment of time to achieve adequate analgesia
  • Time Frame: Days 1 through 10
    Safety Issue?: No
• Assessment of discontinuation rates
  • Time Frame: Days 1 through 10
    Safety Issue?: No
• Assessment of physical disability
  • Time Frame: Randomization, Day 3, Day 5, and End of Study Visit
    Safety Issue?: No
• Assessment of pain characteristics
  • Time Frame: Randomization, Day 5 and End of Study Visit
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Ortho-McNeil Janssen Scientific Affairs, LLC Industry

Overall Clinical Trial Officials and Contacts

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Study Director Ortho-McNeil Janssen Scientific Affairs, LLC  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00986180

Study ID Number: CR015643

ClinicalTrials.gov Identifier: NCT00986180

Health Authority: United States: Institutional Review Board