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PainPhase 3NCT00986180

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

A Phase 3 study testing NUCYNTA and Oxycodone IR in people with Pain and Back Pain, run by Ortho-McNeil Janssen Scientific Affairs, LLC at 74 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Back Pain, Low Back Pain
What is being tested?
NUCYNTA and Oxycodone IR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
667 participants
Where
74 sitesUnited States
Study dates
Sep 2009to Dec 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

United States74 sites

  • Study site

    Akron, Ohio

  • Study site

    Altoona, Pennsylvania

  • Study site

    Andover, Ohio

  • Study site

    Atco, New Jersey

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Avon, Indiana

  • Study site

    Beavercreek, Ohio

  • Study site

    Blackwood, New Jersey

  • Study site

    Boynton Beach, Florida

  • Study site

    Bryan, Texas

  • Study site

    Bulverde, Texas

  • Study site

    Centerville, Ohio

  • Study site

    Charlotte, North Carolina

  • Study site

    Cherry Hill, New Jersey

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Clinton, Utah

  • Study site

    Covington, Louisiana

  • Study site

    Danville, Virginia

  • Study site

    Denver, Colorado

  • Study site

    Edgewater, Florida

  • Study site

    Evansville, Indiana

  • Study site

    Fairfield, Connecticut

  • Study site

    Fall River, Massachusetts

  • Study site

    Florissant, Missouri

  • Study site

    Fresno, California

  • Study site

    Garden Grove, California

  • Study site

    Glendale, California

  • Study site

    Henderson, Nevada

  • Study site

    Hickory, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Jonesboro, Arkansas

  • Study site

    Kalamazoo, Michigan

  • Study site

    Laguna Hills, California

  • Study site

    Lake Jackson, Texas

  • Study site

    Lake Worth, Florida

  • Study site

    Lexington, Kentucky

  • Study site

    Mandeville, Louisiana

  • Study site

    Marion, Ohio

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Mobile, Alabama

  • Study site

    Mooresville, North Carolina

  • Study site

    Murrells Inlet, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    Newport Richey, Florida

  • Study site

    North Dartmouth, Massachusetts

  • Study site

    North Massapequa, New York

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Oldsmar, Florida

  • Study site

    Orem, Utah

  • Study site

    Overland Park, Kansas

  • Study site

    Pahrump, Nevada

  • Study site

    Palm Springs, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Pismo Beach, California

  • Study site

    Plano, Texas

  • Study site

    Saint Cloud, Florida

  • Study site

    San Antonio, Texas

  • Study site

    Savannah, Georgia

  • Study site

    Springfield, Missouri

  • Study site

    Sugar Land, Texas

  • Study site

    Sunset, Louisiana

  • Study site

    Tampa, Florida

  • Study site

    Tyrone, Pennsylvania

  • Study site

    Washington, Missouri

  • Study site

    West Palm Beach, Florida

  • Study site

    Wildomar, California

  • Study site

    Williamsville, New York

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

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.

Read the 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

Being tested
NUCYNTA, Oxycodone IR
Keywords
Acute Low Back Pain, Low Back Pain With Leg Pain Below The Knee, Radiculopathy, Oxycodone, Tapentadol, NUCYNTA
Medical subject headings
Pain, Back Pain, Low Back Pain, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NUCYNTADrug

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

  • Oxycodone IRDrug

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

Study groups in NCT00986180
Study groupRoleWhat they receive
001ExperimentalNUCYNTA 50 75 or 100 mg every 4 to 6 hours for up to 10 days as needed for pain
Receives: Drug: NUCYNTA
002Active comparatorOxycodone IR 5 10 or 15 mg every 4 to 6 hours for up to 10 days as needed for pain
Receives: Drug: Oxycodone IR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0 hour (prior to first dose) and 120 hours

Secondary outcomes (32)

  1. Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (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 2 days.

    Measured: Day 0 and Day 2

  2. SPID for Low Back Pain - Summary Statistics at 3 Days (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 3 days.

    Measured: Day 0 and Day 3

  3. SPID for Low Back Pain - Summary Statistics at 10 Days (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 10 days.

    Measured: Day 0 and Day 10

  4. SPID for Index Leg Pain - Summary Statistics at 2 Days (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 2 days.

    Measured: Day 0 and Day 2

  5. SPID for Index Leg Pain - Summary Statistics at 3 Days (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 3 days.

    Measured: Day 0 and Day 3

  6. SPID for Index Leg Pain - Summary Statistics at 5 Days (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 5 days.

    Measured: Day 0 and Day 5

  7. SPID for Index Leg Pain - Summary Statistics at 10 Days (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 10 days.

    Measured: Day 0 and Day 10

  8. Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days

    Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days.

    Measured: Day 0 and Day 5

  9. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.

    Measured: Day 0 and Day 5

  10. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.

    Measured: Day 0 and Day 10

  11. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.

    Measured: Day 0 and Day 5

  12. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.

    Measured: Day 0 and Day 10

  13. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness.

    Measured: Day 0 and Day 5

  14. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness.

    Measured: Day 0 and Day 10

  15. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.

    Measured: Day 0 and Day 5

  16. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.

    Measured: Day 0 and Day 10

  17. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.

    Measured: Day 0 and Day 5

  18. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.

    Measured: Day 0 and Day 10

  19. Patient Global Impression of Change at End of Study

    Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

    Measured: Day 0 and Day 10/last visit

  20. Patient Global Impression of Change at End of Study

    Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

    Measured: Day 0 and Day 10/lst visit

  21. Clinician Global Impression of Change at End of Study

    Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

    Measured: Day 0 and Day 10/last visit

  22. Satisfaction With Treatment at Day 5

    The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).

    Measured: Day 0 and Day 5

  23. Satisfaction With Treatment at End of Study

    The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).

    Measured: Day 0 and Day 10/last visit

  24. Incidence of 30% Responders Without Nausea or Vomiting at Day 5

    Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.

    Measured: Day 0 and Day 5

  25. Incidence of 50% Responders Without Nausea or Vomiting at Day 5

    Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.

    Measured: Day 0 and Day 5

  26. Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation

    Measured: Day 0 and Day 10/last visit

  27. Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event

    Number of subjects that reported nausea as a treatment-emergent adverse event during the study.

    Measured: Day 0 and Day 10/last visit

  28. Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event

    Number of subjects that reported vomiting as a treatment emergent adverse event during the study.

    Measured: Day 0 and Day 10/last visit

  29. Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event

    Number of subjects that reported constipation as a treatment emergent adverse event during the study.

    Measured: Day 0 and Day 10/last visit

  30. Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event

    Number of subjects that reported pruritus as a treatment emergent adverse event during the study.

    Measured: Day 0 and Day 10/last visit

  31. Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain

    30% response means >= 30% reduction from baseline in low back pain intensity score.

    Measured: Day 0 and Day 10/last visit

  32. Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain

    50% response means >= 50% reduction from baseline in low back pain intensity score.

    Measured: Day 0 and Day 10/last visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00986180
Sponsor's protocol ID
CR015643
Other IDs
R331333PAI3025, KF5503/51
Status last verified
Dec 2012
First submitted
25 Sep 2009
Last updated
19 Dec 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 23703422

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NUCYNTA and Oxycodone IR in people with Pain and Back Pain, run by Ortho-McNeil Janssen Scientific Affairs, LLC at 74 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) (time frame: 0 hour (prior to first dose) and 120 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00986180, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2012.

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