search
Back to results

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

Primary Purpose

Pain, Back Pain, Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NUCYNTA
Oxycodone IR
Sponsored by
Ortho-McNeil Janssen Scientific Affairs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Acute Low Back Pain, Low Back Pain With Leg Pain Below The Knee, Radiculopathy, Oxycodone, Tapentadol, NUCYNTA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

001

002

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2009
Last Updated
December 17, 2012
Sponsor
Ortho-McNeil Janssen Scientific Affairs, LLC
Collaborators
Grünenthal GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT00986180
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ortho-McNeil Janssen Scientific Affairs, LLC
Collaborators
Grünenthal GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
001
Arm Type
Experimental
Arm Description
NUCYNTA 50 75 or 100 mg every 4 to 6 hours for up to 10 days as needed for pain
Arm Title
002
Arm Type
Active Comparator
Arm Description
Oxycodone IR 5 10 or 15 mg every 4 to 6 hours for up to 10 days as needed for pain
Intervention Type
Drug
Intervention Name(s)
NUCYNTA
Intervention Description
50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain
Intervention Type
Drug
Intervention Name(s)
Oxycodone IR
Intervention Description
5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain
Primary Outcome Measure Information:
Title
Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation)
Description
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.
Time Frame
0 hour (prior to first dose) and 120 hours
Secondary Outcome Measure Information:
Title
Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)
Description
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.
Time Frame
Day 0 and Day 2
Title
SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation)
Description
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.
Time Frame
Day 0 and Day 3
Title
SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation)
Description
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.
Time Frame
Day 0 and Day 10
Title
SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation)
Description
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.
Time Frame
Day 0 and Day 2
Title
SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation)
Description
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.
Time Frame
Day 0 and Day 3
Title
SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation)
Description
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.
Time Frame
Day 0 and Day 5
Title
SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation)
Description
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.
Time Frame
Day 0 and Day 10
Title
Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days
Description
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.
Time Frame
Day 0 and Day 5
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5
Description
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.
Time Frame
Day 0 and Day 5
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit
Description
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.
Time Frame
Day 0 and Day 10
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5
Description
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.
Time Frame
Day 0 and Day 5
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit
Description
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.
Time Frame
Day 0 and Day 10
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5
Description
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.
Time Frame
Day 0 and Day 5
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit
Description
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.
Time Frame
Day 0 and Day 10
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5
Description
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.
Time Frame
Day 0 and Day 5
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit
Description
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.
Time Frame
Day 0 and Day 10
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5
Description
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.
Time Frame
Day 0 and Day 5
Title
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit
Description
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.
Time Frame
Day 0 and Day 10
Title
Patient Global Impression of Change at End of Study
Description
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).
Time Frame
Day 0 and Day 10/last visit
Title
Patient Global Impression of Change at End of Study
Description
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).
Time Frame
Day 0 and Day 10/lst visit
Title
Clinician Global Impression of Change at End of Study
Description
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).
Time Frame
Day 0 and Day 10/last visit
Title
Satisfaction With Treatment at Day 5
Description
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).
Time Frame
Day 0 and Day 5
Title
Satisfaction With Treatment at End of Study
Description
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).
Time Frame
Day 0 and Day 10/last visit
Title
Incidence of 30% Responders Without Nausea or Vomiting at Day 5
Description
Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.
Time Frame
Day 0 and Day 5
Title
Incidence of 50% Responders Without Nausea or Vomiting at Day 5
Description
Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.
Time Frame
Day 0 and Day 5
Title
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation
Time Frame
Day 0 and Day 10/last visit
Title
Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event
Description
Number of subjects that reported nausea as a treatment-emergent adverse event during the study.
Time Frame
Day 0 and Day 10/last visit
Title
Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event
Description
Number of subjects that reported vomiting as a treatment emergent adverse event during the study.
Time Frame
Day 0 and Day 10/last visit
Title
Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event
Description
Number of subjects that reported constipation as a treatment emergent adverse event during the study.
Time Frame
Day 0 and Day 10/last visit
Title
Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event
Description
Number of subjects that reported pruritus as a treatment emergent adverse event during the study.
Time Frame
Day 0 and Day 10/last visit
Title
Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain
Description
30% response means >= 30% reduction from baseline in low back pain intensity score.
Time Frame
Day 0 and Day 10/last visit
Title
Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain
Description
50% response means >= 50% reduction from baseline in low back pain intensity score.
Time Frame
Day 0 and Day 10/last visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
Organizational Affiliation
Ortho-McNeil Janssen Scientific Affairs, LLC
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Jonesboro
State/Province
Arkansas
Country
United States
City
Fresno
State/Province
California
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Laguna Hills
State/Province
California
Country
United States
City
Palm Springs
State/Province
California
Country
United States
City
Pismo Beach
State/Province
California
Country
United States
City
Wildomar
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Fairfield
State/Province
Connecticut
Country
United States
City
Boynton Beach
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Edgewater
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Lake Worth
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Newport Richey
State/Province
Florida
Country
United States
City
Oldsmar
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
Saint Cloud
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Savannah
State/Province
Georgia
Country
United States
City
Avon
State/Province
Indiana
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Covington
State/Province
Louisiana
Country
United States
City
Mandeville
State/Province
Louisiana
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Sunset
State/Province
Louisiana
Country
United States
City
Fall River
State/Province
Massachusetts
Country
United States
City
N Dartmouth
State/Province
Massachusetts
Country
United States
City
Kalamazoo
State/Province
Michigan
Country
United States
City
Florissant
State/Province
Missouri
Country
United States
City
Springfield
State/Province
Missouri
Country
United States
City
Washington
State/Province
Missouri
Country
United States
City
Henderson
State/Province
Nevada
Country
United States
City
Pahrump
State/Province
Nevada
Country
United States
City
Atco
State/Province
New Jersey
Country
United States
City
Blackwood
State/Province
New Jersey
Country
United States
City
Cherry Hill
State/Province
New Jersey
Country
United States
City
North Massapequa
State/Province
New York
Country
United States
City
Williamsville
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Mooresville
State/Province
North Carolina
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Andover
State/Province
Ohio
Country
United States
City
Beavercreek
State/Province
Ohio
Country
United States
City
Centerville
State/Province
Ohio
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Marion
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Altoona
State/Province
Pennsylvania
Country
United States
City
Tyrone
State/Province
Pennsylvania
Country
United States
City
Murrells Inlet
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Bryan
State/Province
Texas
Country
United States
City
Bulverde
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Lake Jackson
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Sugar Land
State/Province
Texas
Country
United States
City
Clinton
State/Province
Utah
Country
United States
City
Orem
State/Province
Utah
Country
United States
City
Danville
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23703422
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs