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

NCT ID: NCT00986180

Last Updated: 2012-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 667 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-12-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

001

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

Group Type: EXPERIMENTAL

NUCYNTA

Intervention Type: DRUG

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

002

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

Group Type: ACTIVE_COMPARATOR

Oxycodone IR

Intervention Type: DRUG

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

Interventions

NUCYNTA

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

Intervention Type: DRUG

Oxycodone IR

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: collaborator

Ortho-McNeil Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Ortho-McNeil Janssen Scientific Affairs, LLC

Locations

Mobile, Alabama, United States

Phoenix, Arizona, United States

Jonesboro, Arkansas, United States

Fresno, California, United States

Garden Grove, California, United States

Glendale, California, United States

Laguna Hills, California, United States

Palm Springs, California, United States

Pismo Beach, California, United States

Wildomar, California, United States

Denver, Colorado, United States

Fairfield, Connecticut, United States

Boynton Beach, Florida, United States

Clearwater, Florida, United States

Edgewater, Florida, United States

Jacksonville, Florida, United States

Lake Worth, Florida, United States

Miami, Florida, United States

Newport Richey, Florida, United States

Oldsmar, Florida, United States

Pembroke Pines, Florida, United States

Saint Cloud, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Savannah, Georgia, United States

Avon, Indiana, United States

Evansville, Indiana, United States

Overland Park, Kansas, United States

Lexington, Kentucky, United States

Covington, Louisiana, United States

Mandeville, Louisiana, United States

Metairie, Louisiana, United States

New Orleans, Louisiana, United States

Sunset, Louisiana, United States

Fall River, Massachusetts, United States

North Dartmouth, Massachusetts, United States

Kalamazoo, Michigan, United States

Florissant, Missouri, United States

Springfield, Missouri, United States

Washington, Missouri, United States

Henderson, Nevada, United States

Pahrump, Nevada, United States

Atco, New Jersey, United States

Blackwood, New Jersey, United States

Cherry Hill, New Jersey, United States

North Massapequa, New York, United States

Williamsville, New York, United States

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Mooresville, North Carolina, United States

Winston-Salem, North Carolina, United States

Akron, Ohio, United States

Andover, Ohio, United States

Beavercreek, Ohio, United States

Centerville, Ohio, United States

Cincinnati, Ohio, United States

Marion, Ohio, United States

Oklahoma City, Oklahoma, United States

Altoona, Pennsylvania, United States

Tyrone, Pennsylvania, United States

Murrells Inlet, South Carolina, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Bryan, Texas, United States

Bulverde, Texas, United States

Houston, Texas, United States

Lake Jackson, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Sugar Land, Texas, United States

Clinton, Utah, United States

Orem, Utah, United States

Danville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23703422 (View on PubMed)

Other Identifiers

R331333PAI3025

Identifier Type: OTHER

Identifier Source: secondary_id

KF5503/51

Identifier Type: OTHER

Identifier Source: secondary_id

CR015643

Identifier Type: -

Identifier Source: org_study_id