Clinical trial NCT00986180: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Back Pain
Low Back Pain
Back Pain With Radiation
Keywords: Acute Low Back Pain
Low Back Pain With Leg Pain Below The Knee
Radiculopathy, Oxycodone
Tapentadol
NUCYNTA
Lead sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
Collaborators: name: Grünenthal GmbH
First posted: 2009-09-29
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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

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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)
timeFrame: Day 0 and Day 2
measure: SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation)
timeFrame: Day 0 and Day 3
measure: SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation)
timeFrame: Day 0 and Day 10
measure: SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation)
timeFrame: Day 0 and Day 2
measure: SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation)
timeFrame: Day 0 and Day 3
measure: SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation)
timeFrame: Day 0 and Day 5
measure: SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation)
timeFrame: Day 0 and Day 10
measure: Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days
timeFrame: Day 0 and Day 5
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5
timeFrame: Day 0 and Day 5
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit
timeFrame: Day 0 and Day 10
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5
timeFrame: Day 0 and Day 5
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit
timeFrame: Day 0 and Day 10
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5
timeFrame: Day 0 and Day 5
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit
timeFrame: Day 0 and Day 10
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5
timeFrame: Day 0 and Day 5
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit
timeFrame: Day 0 and Day 10
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5
timeFrame: Day 0 and Day 5
measure: SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit
timeFrame: Day 0 and Day 10
measure: Patient Global Impression of Change at End of Study
timeFrame: Day 0 and Day 10/last visit
measure: Patient Global Impression of Change at End of Study
timeFrame: Day 0 and Day 10/lst visit
measure: Clinician Global Impression of Change at End of Study
timeFrame: Day 0 and Day 10/last visit
measure: Satisfaction With Treatment at Day 5
timeFrame: Day 0 and Day 5
measure: Satisfaction With Treatment at End of Study
timeFrame: Day 0 and Day 10/last visit
measure: Incidence of 30% Responders Without Nausea or Vomiting at Day 5
timeFrame: Day 0 and Day 5
measure: Incidence of 50% Responders Without Nausea or Vomiting at Day 5
timeFrame: Day 0 and Day 5
measure: Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation
timeFrame: Day 0 and Day 10/last visit
measure: Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event
timeFrame: Day 0 and Day 10/last visit
measure: Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event
timeFrame: Day 0 and Day 10/last visit
measure: Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event
timeFrame: Day 0 and Day 10/last visit
measure: Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event
timeFrame: Day 0 and Day 10/last visit
measure: Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain
timeFrame: Day 0 and Day 10/last visit
measure: Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain
timeFrame: Day 0 and Day 10/last visit
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Fairfield
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Edgewater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Newport Richey
country: United States
state: Florida
city: Oldsmar
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Saint Cloud
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Avon
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Covington
country: United States
state: Louisiana
city: Mandeville
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Sunset
country: United States
state: Louisiana
city: Fall River
country: United States
state: Massachusetts
city: N Dartmouth
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Florissant
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Pahrump
country: United States
state: Nevada
city: Atco
country: United States
state: New Jersey
city: Blackwood
country: United States
state: New Jersey
city: Cherry Hill
country: United States
state: New Jersey
city: North Massapequa
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Mooresville
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Andover
country: United States
state: Ohio
city: Beavercreek
country: United States
state: Ohio
city: Centerville
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Altoona
country: United States
state: Pennsylvania
city: Tyrone
country: United States
state: Pennsylvania
city: Murrells Inlet
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: Bulverde
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Clinton
country: United States
state: Utah
city: Orem
country: United States
state: Utah
city: Danville
country: United States
state: Virginia
Study officials:
affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
name: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Biondi D, Xiang J, Benson C, Etropolski M, Moskovitz B, Rauschkolb C. Tapentadol immediate release versus oxycodone immediate release for treatment of acute low back pain. Pain Physician. 2013 May-Jun;16(3):E237-46.