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

NCT00986180 | Completed Phase 3 Results

• 3 other identifiers: CR015643R331333PAI3025KF5503/51
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 74

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation)

  Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.

  0 hour (prior to first dose) and 120 hours

Secondary Outcomes (32)

• Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)

  Day 0 and Day 2

• SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation)

  Day 0 and Day 3

• SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation)

  Day 0 and Day 10

• SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation)

  Day 0 and Day 2

• SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation)

  Day 0 and Day 3

Study Arms (2)

001

EXPERIMENTAL

NUCYNTA 50 75 or 100 mg every 4 to 6 hours for up to 10 days as needed for pain

Drug: NUCYNTA

002

ACTIVE COMPARATOR

Oxycodone IR 5 10 or 15 mg every 4 to 6 hours for up to 10 days as needed for pain

Drug: Oxycodone IR

Interventions

NUCYNTA DRUG

50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain

001

Oxycodone IR DRUG

5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain

002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead
• Grünenthal GmbH: collaborator

Study Sites (74)

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Jonesboro, Arkansas, United States

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Fresno, California, United States

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Garden Grove, California, United States

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Glendale, California, United States

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Laguna Hills, California, United States

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Palm Springs, California, United States

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Pismo Beach, California, United States

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Wildomar, California, United States

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Denver, Colorado, United States

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Fairfield, Connecticut, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Edgewater, Florida, United States

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Jacksonville, Florida, United States

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Lake Worth, Florida, United States

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Miami, Florida, United States

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Newport Richey, Florida, United States

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Oldsmar, Florida, United States

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Pembroke Pines, Florida, United States

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Saint Cloud, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Avon, Indiana, United States

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Evansville, Indiana, United States

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Overland Park, Kansas, United States

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Lexington, Kentucky, United States

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Covington, Louisiana, United States

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Mandeville, Louisiana, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Sunset, Louisiana, United States

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Fall River, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Florissant, Missouri, United States

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Springfield, Missouri, United States

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Washington, Missouri, United States

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Henderson, Nevada, United States

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Pahrump, Nevada, United States

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Atco, New Jersey, United States

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Blackwood, New Jersey, United States

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Cherry Hill, New Jersey, United States

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North Massapequa, New York, United States

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Williamsville, New York, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Mooresville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Andover, Ohio, United States

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Beavercreek, Ohio, United States

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Centerville, Ohio, United States

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Cincinnati, Ohio, United States

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Marion, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Tyrone, Pennsylvania, United States

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Murrells Inlet, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Bryan, Texas, United States

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Bulverde, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Clinton, Utah, United States

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Orem, Utah, United States

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Danville, Virginia, United States

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Related Publications (1)

• 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.

  PMID: 23703422 DERIVED

MeSH Terms

Conditions

Pain; Back Pain; Low Back Pain; Radiculopathy

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

There were 19 subjects either did not take medication or did not have verifiable drug exposure. 2 subjects were randomized in two different sites, only one site information were included. 1 subject were randomized in error.

Results Point of Contact

• Title: Vice President, Medical Affairs, Internal Medicine
• Organization: Janssen Pharmaceuticals

1 908 218-7250

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 29, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 19, 2012
• Results First Posted: February 29, 2012

Record last verified: 2012-12

Locations

US (74)