NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acu… (NCT00986180) | Clinical Trial Compass
CompletedPhase 3
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
United States667 participantsStarted 2009-09
Plain-language summary
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
What they're measuring
1
Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation)
Timeframe: 0 hour (prior to first dose) and 120 hours