Pain, Back Pain, Low Back Pain, Back Pain With Radiation
Conditions
Keywords
Acute Low Back Pain, Low Back Pain With Leg Pain Below The Knee, Radiculopathy, Oxycodone, Tapentadol, NUCYNTA
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
Interventions
DRUGNUCYNTA
50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain
DRUGOxycodone IR
5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain
Sponsors
Grünenthal GmbH
Ortho-McNeil Janssen Scientific Affairs, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | 0 hour (prior to first dose) and 120 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | Day 0 and Day 3 | 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) | Day 0 and Day 10 | 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) | Day 0 and Day 2 | 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) | Day 0 and Day 3 | 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) | Day 0 and Day 5 | 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) | Day 0 and Day 10 | 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 | Day 0 and Day 5 | 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 | Day 0 and 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 | Day 0 and Day 10 | 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 | Day 0 and 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 | Day 0 and Day 10 | 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 | Day 0 and 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 | Day 0 and Day 10 | 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 | Day 0 and 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 | Day 0 and Day 10 | 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. |
| Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | Day 0 and Day 2 | 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. |
| SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit | Day 0 and Day 10 | 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 | Day 0 and Day 10/last visit | 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 | Day 0 and Day 10/last visit | 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 | Day 0 and 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 | Day 0 and Day 10/last visit | 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 | Day 0 and 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 | Day 0 and 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 | Day 0 and Day 10/last visit | — |
| Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event | Day 0 and Day 10/last visit | 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 | Day 0 and Day 10/last visit | 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 | Day 0 and Day 10/last visit | 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 | Day 0 and Day 10/last visit | 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 | Day 0 and Day 10/last visit | 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 | Day 0 and Day 10/last visit | 50% response means \>= 50% reduction from baseline in low back pain intensity score. |
| SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5 | Day 0 and 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. |
Countries
United States
Participant flow
Pre-assignment details
19 subjects either did not take medication or did not have verifiable drug exposure. 2 subjects were randomized in two different sites, information was included for only one site. 1 subject was randomized in error.
Participants by arm
| Arm | Count |
|---|---|
| NUCYNTA 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | 321 |
| Oxycodone IR 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg | 324 |
| Total | 645 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 21 | 23 |
| Overall Study | Lack of Efficacy | 4 | 3 |
| Overall Study | Lost to Follow-up | 5 | 7 |
| Overall Study | Miscellanies | 10 | 11 |
| Overall Study | Physician Decision | 1 | 3 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 9 |
Baseline characteristics
| Characteristic | NUCYNTA | Oxycodone IR | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 39 Participants | 26 Participants | 65 Participants |
| Age, Categorical Between 18 and 65 years | 282 Participants | 297 Participants | 579 Participants |
| Age Continuous | 45.7 years STANDARD_DEVIATION 14.18 | 45.1 years STANDARD_DEVIATION 14.36 | 45.4 years STANDARD_DEVIATION 14.26 |
| Baseline BMI | 30.9 kg/m^2 STANDARD_DEVIATION 8.83 | 30.4 kg/m^2 STANDARD_DEVIATION 8.63 | 30.6 kg/m^2 STANDARD_DEVIATION 8.72 |
| Baseline Index Leg Pain Intensity | 6.2 Units on a scale STANDARD_DEVIATION 2.21 | 6.2 Units on a scale STANDARD_DEVIATION 2.1 | 6.2 Units on a scale STANDARD_DEVIATION 2.15 |
| Baseline Low Back Pain Intensity | 7.2 Units on a scale STANDARD_DEVIATION 1.66 | 7.2 Units on a scale STANDARD_DEVIATION 1.54 | 7.2 Units on a scale STANDARD_DEVIATION 1.6 |
| Ethnicity Hispanic or Latino | 43 participants | 39 participants | 82 participants |
| Ethnicity Not Hispanic or Latino | 278 participants | 283 participants | 561 participants |
| Ethnicity Not Reported | 0 participants | 2 participants | 2 participants |
| Region of Enrollment UNITED STATES | 321 participants | 324 participants | 645 participants |
| Sex: Female, Male Female | 145 Participants | 176 Participants | 321 Participants |
| Sex: Female, Male Male | 176 Participants | 148 Participants | 324 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 141 / 321 | 165 / 324 |
| serious Total, serious adverse events | 2 / 321 | 3 / 324 |
Outcome results
Primary
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.
Time frame: 0 hour (prior to first dose) and 120 hours
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | 264.6 Units on a scale | Standard Error 11.43 |
| Oxycodone IR | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | 264.0 Units on a scale | Standard Error 11.22 |
p-value: 0.970395% CI: [-32.1, 30.9]ANCOVA
Secondary
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).
Time frame: Day 0 and Day 10/last visit
Population: Intent-To-Treat Population with CGIC assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | Clinician Global Impression of Change at End of Study | 2.1 Units on a Scale | Standard Deviation 0.99 |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | 2.1 Units on a Scale | Standard Deviation 0.93 |
Secondary
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).
Time frame: Day 0 and Day 10/last visit
Population: Intent-To-Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUCYNTA | Clinician Global Impression of Change at End of Study | 1 = Very much improved | 78 Units on a Scale |
| NUCYNTA | Clinician Global Impression of Change at End of Study | 2 = Much improved | 127 Units on a Scale |
| NUCYNTA | Clinician Global Impression of Change at End of Study | 3 = Minimally improved | 60 Units on a Scale |
| NUCYNTA | Clinician Global Impression of Change at End of Study | 4 = No change | 21 Units on a Scale |
| NUCYNTA | Clinician Global Impression of Change at End of Study | 5 = Minimally worse | 2 Units on a Scale |
| NUCYNTA | Clinician Global Impression of Change at End of Study | 6 = Much worse | 1 Units on a Scale |
| NUCYNTA | Clinician Global Impression of Change at End of Study | 7 = Very much worse | 2 Units on a Scale |
| NUCYNTA | Clinician Global Impression of Change at End of Study | Missing | 12 Units on a Scale |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | Missing | 13 Units on a Scale |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | 1 = Very much improved | 77 Units on a Scale |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | 5 = Minimally worse | 1 Units on a Scale |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | 2 = Much improved | 130 Units on a Scale |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | 7 = Very much worse | 0 Units on a Scale |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | 3 = Minimally improved | 70 Units on a Scale |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | 6 = Much worse | 0 Units on a Scale |
| Oxycodone IR | Clinician Global Impression of Change at End of Study | 4 = No change | 18 Units on a Scale |
p-value: 0.5208Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Day 0 and Day 5
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUCYNTA | Incidence of 30% Responders Without Nausea or Vomiting at Day 5 | 117 Participants |
| Oxycodone IR | Incidence of 30% Responders Without Nausea or Vomiting at Day 5 | 104 Participants |
p-value: 0.1454Fisher Exact
Secondary
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.
Time frame: Day 0 and Day 5
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUCYNTA | Incidence of 50% Responders Without Nausea or Vomiting at Day 5 | 72 Participants |
| Oxycodone IR | Incidence of 50% Responders Without Nausea or Vomiting at Day 5 | 60 Participants |
p-value: 0.1541Fisher Exact
Secondary
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.
Time frame: Day 0 and Day 10/last visit
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NUCYNTA | Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain | 42.93 Hours |
| Oxycodone IR | Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain | 44.27 Hours |
p-value: 0.5828Log Rank
Secondary
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.
Time frame: Day 0 and Day 10/last visit
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NUCYNTA | Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain | 92.05 Hours |
| Oxycodone IR | Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain | 107.45 Hours |
p-value: 0.9084Log Rank
Secondary
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).
Time frame: Day 0 and Day 10/last visit
Population: Intent-To-Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUCYNTA | Patient Global Impression of Change at End of Study | 1 = Very much improved | 89 Units on a Scale |
| NUCYNTA | Patient Global Impression of Change at End of Study | 2 = Much improved | 111 Units on a Scale |
| NUCYNTA | Patient Global Impression of Change at End of Study | 3 = Minimally improved | 59 Units on a Scale |
| NUCYNTA | Patient Global Impression of Change at End of Study | 4 = No change | 27 Units on a Scale |
| NUCYNTA | Patient Global Impression of Change at End of Study | 5 = Minimally worse | 2 Units on a Scale |
| NUCYNTA | Patient Global Impression of Change at End of Study | 6 = Much worse | 1 Units on a Scale |
| NUCYNTA | Patient Global Impression of Change at End of Study | 7 = Very much worse | 1 Units on a Scale |
| NUCYNTA | Patient Global Impression of Change at End of Study | Missing | 12 Units on a Scale |
| Oxycodone IR | Patient Global Impression of Change at End of Study | Missing | 13 Units on a Scale |
| Oxycodone IR | Patient Global Impression of Change at End of Study | 1 = Very much improved | 90 Units on a Scale |
| Oxycodone IR | Patient Global Impression of Change at End of Study | 5 = Minimally worse | 0 Units on a Scale |
| Oxycodone IR | Patient Global Impression of Change at End of Study | 2 = Much improved | 116 Units on a Scale |
| Oxycodone IR | Patient Global Impression of Change at End of Study | 7 = Very much worse | 1 Units on a Scale |
| Oxycodone IR | Patient Global Impression of Change at End of Study | 3 = Minimally improved | 67 Units on a Scale |
| Oxycodone IR | Patient Global Impression of Change at End of Study | 6 = Much worse | 0 Units on a Scale |
| Oxycodone IR | Patient Global Impression of Change at End of Study | 4 = No change | 24 Units on a Scale |
p-value: 0.7201Cochran-Mantel-Haenszel
Secondary
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).
Time frame: Day 0 and Day 10/lst visit
Population: Intent-To-Treat Population with PGIC assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | Patient Global Impression of Change at End of Study | 2.1 Units on a Scale | Standard Deviation 1.04 |
| Oxycodone IR | Patient Global Impression of Change at End of Study | 2.1 Units on a Scale | Standard Deviation 0.96 |
Secondary
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).
Time frame: Day 0 and Day 5
Population: Intent-To-Treat Population with subject's satisfaction assessment on Day 5.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | Satisfaction With Treatment at Day 5 | 2.0 Units on a Scale | Standard Deviation 1.19 |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | 2.0 Units on a Scale | Standard Deviation 1.18 |
Secondary
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).
Time frame: Day 0 and Day 5
Population: Intent-To-Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUCYNTA | Satisfaction With Treatment at Day 5 | 4 = Neither satisfied nor dissatisfied | 16 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at Day 5 | 2 = Somewhat satisfied | 102 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at Day 5 | 5 = Slightly dissatisfied | 8 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at Day 5 | 1 = Very satisfied | 113 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at Day 5 | 6 = Somewhat dissatisfied | 2 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at Day 5 | 3 = Slightly satisfied | 31 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at Day 5 | Missing | 27 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at Day 5 | 7 = Very dissatisfied | 3 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | Missing | 34 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | 1 = Very satisfied | 92 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | 2 = Somewhat satisfied | 132 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | 3 = Slightly satisfied | 32 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | 4 = Neither satisfied nor dissatisfied | 5 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | 5 = Slightly dissatisfied | 7 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | 7 = Very dissatisfied | 4 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at Day 5 | 6 = Somewhat dissatisfied | 5 Units on a Scale |
p-value: 0.0401Cochran-Mantel-Haenszel
Secondary
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).
Time frame: Day 0 and Day 10/last visit
Population: Intent-To-Treat Population with subject's satisfaction assessment at end of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | Satisfaction With Treatment at End of Study | 2.0 Units on a Scale | Standard Deviation 1.49 |
| Oxycodone IR | Satisfaction With Treatment at End of Study | 2.0 Units on a Scale | Standard Deviation 1.48 |
Secondary
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).
Time frame: Day 0 and Day 10/last visit
Population: Intent-To-Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUCYNTA | Satisfaction With Treatment at End of Study | 1 = Very satisfied | 146 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at End of Study | 5 = Slightly dissatisfied | 7 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at End of Study | 3 = Slightly satisfied | 28 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at End of Study | 6 = Somewhat dissatisfied | 8 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at End of Study | 2 = Somewhat satisfied | 84 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at End of Study | 7 = Very dissatisfied | 10 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at End of Study | 4 = Neither satisfied nor dissatisfied | 7 Units on a Scale |
| NUCYNTA | Satisfaction With Treatment at End of Study | Missing | 12 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at End of Study | 4 = Neither satisfied nor dissatisfied | 14 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at End of Study | 1 = Very satisfied | 148 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at End of Study | 2 = Somewhat satisfied | 87 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at End of Study | 3 = Slightly satisfied | 29 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at End of Study | Missing | 13 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at End of Study | 5 = Slightly dissatisfied | 3 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at End of Study | 6 = Somewhat dissatisfied | 4 Units on a Scale |
| Oxycodone IR | Satisfaction With Treatment at End of Study | 7 = Very dissatisfied | 13 Units on a Scale |
p-value: 0.4679Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Day 0 and Day 10
Population: Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit | -2.4 Units on a Scale | Standard Deviation 2.74 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit | -2.2 Units on a Scale | Standard Deviation 2.39 |
p-value: 0.6137Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 5
Population: Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5 | -2.0 score of scale | Standard Deviation 2.46 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5 | -1.9 score of scale | Standard Deviation 2.31 |
p-value: 0.5411Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 10
Population: Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit | -3.1 Units on a Scale | Standard Deviation 2.35 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit | -2.9 Units on a Scale | Standard Deviation 2.31 |
p-value: 0.4115Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 5
Population: Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5 | -2.4 Units on a Scale | Standard Deviation 2.05 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5 | -2.4 Units on a Scale | Standard Deviation 2.14 |
p-value: 0.888Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 10
Population: Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit | -3.3 Units on a Scale | Standard Deviation 2.46 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit | -3.2 Units on a Scale | Standard Deviation 2.29 |
p-value: 0.7846Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 5
Population: Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5 | -2.6 Units on a Scale | Standard Deviation 2.23 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5 | -2.5 Units on a Scale | Standard Deviation 2.09 |
p-value: 0.8495Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 10
Population: Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit | -1.8 Units on a Scale | Standard Deviation 1.94 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit | -1.6 Units on a Scale | Standard Deviation 1.99 |
p-value: 0.3147Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 5
Population: Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5 | -1.5 Units on a Scale | Standard Deviation 1.92 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5 | -1.4 Units on a Scale | Standard Deviation 1.85 |
p-value: 0.479Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 10
Population: Intent-To-Treat Population with both baseline and Day 10 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit | -2.7 Units on a Scale | Standard Deviation 2.04 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit | -2.5 Units on a Scale | Standard Deviation 1.91 |
p-value: 0.4882Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 5
Population: Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5 | -2.2 Units on a Scale | Standard Deviation 1.84 |
| Oxycodone IR | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5 | -2.1 Units on a Scale | Standard Deviation 1.74 |
p-value: 0.7246Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0 and Day 10
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation) | 488.0 Units on a Scale | Standard Error 20.71 |
| Oxycodone IR | SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation) | 476.4 Units on a Scale | Standard Error 20.33 |
p-value: 0.689795% CI: [-68.6, 45.4]ANCOVA
Secondary
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.
Time frame: Day 0 and Day 2
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) | 73.6 Units on a Scale | Standard Error 4.34 |
| Oxycodone IR | SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) | 72.1 Units on a Scale | Standard Error 4.26 |
p-value: 0.797395% CI: [-13.5, 10.4]ANCOVA
Secondary
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.
Time frame: Day 0 and Day 3
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation) | 125.5 Units on a Scale | Standard Error 6.63 |
| Oxycodone IR | SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation) | 123.0 Units on a Scale | Standard Error 6.51 |
p-value: 0.788295% CI: [-20.8, 15.8]ANCOVA
Secondary
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.
Time frame: Day 0 and Day 5
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation) | 239.2 Units on a Scale | Standard Error 11.29 |
| Oxycodone IR | SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation) | 234.1 Units on a Scale | Standard Error 11.08 |
p-value: 0.749195% CI: [-36.1, 26]ANCOVA
Secondary
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.
Time frame: Day 0 and Day 10
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) | 540.2 Units on a scale | Standard Error 21.23 |
| Oxycodone IR | SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) | 538.6 Units on a scale | Standard Error 20.84 |
p-value: 0.956295% CI: [-60.1, 56.8]ANCOVA
Secondary
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.
Time frame: Day 0 and Day 3
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | 137.2 Units on a scale | Standard Error 6.6 |
| Oxycodone IR | SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | 138.1 Units on a scale | Standard Error 6.47 |
p-value: 0.928295% CI: [-17.3, 19]ANCOVA
Secondary
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.
Time frame: Day 0 and Day 10/last visit
Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUCYNTA | Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event | 7 Participants |
| Oxycodone IR | Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event | 23 Participants |
95% CI: [1.45, 8.11]Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Day 0 and Day 10/last visit
Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUCYNTA | Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event | 51 Participants |
| Oxycodone IR | Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event | 67 Participants |
95% CI: [0.92, 2.06]Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Day 0 and Day 10/last visit
Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUCYNTA | Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event | 27 Participants |
| Oxycodone IR | Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event | 26 Participants |
95% CI: [0.54, 1.67]Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Day 0 and Day 10/last visit
Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUCYNTA | Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event | 51 Participants |
| Oxycodone IR | Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event | 80 Participants |
95% CI: [1.17, 2.57]Cochran-Mantel-Haenszel
Secondary
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation
Time frame: Day 0 and Day 10/last visit
Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Liver function test abnormal | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Nausea | 6 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Musculoskeletal and connective tissue disorders | 2 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | General disorders and admin. site conditions | 2 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Back pain | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Vision blurred | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Muscle spasms | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Fatigue | 2 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Neoplasms benign, malignant and unspecified | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Vomiting | 5 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Lung cancer metastatic | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Infections and infestations | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Nervous system disorders | 6 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Eye disorders | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Dizziness | 3 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Upper respiratory tract infection | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Somnolence | 2 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Diarrhea | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Headache | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Convulsion | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Injury, poisoning and procedural complications | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Syncope | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Gastrointestinal disorders | 11 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Psychiatric disorders | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Contusion | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Depression | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Abdominal discomfort | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Skin and subcutaneous tissue disorders | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Investigations | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Rash | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Number of subjects with adverse events | 21 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Pruritus | 0 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Hepatic enzyme increased | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Rash generalized | 1 Participants |
| NUCYNTA | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Constipation | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Rash generalized | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Number of subjects with adverse events | 26 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Eye disorders | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Vision blurred | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Gastrointestinal disorders | 14 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Nausea | 9 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Vomiting | 6 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Diarrhea | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Abdominal discomfort | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Constipation | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | General disorders and admin. site conditions | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Fatigue | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Infections and infestations | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Upper respiratory tract infection | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Injury, poisoning and procedural complications | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Contusion | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Investigations | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Hepatic enzyme increased | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Liver function test abnormal | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Musculoskeletal and connective tissue disorders | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Back pain | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Muscle spasms | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Neoplasms benign, malignant and unspecified | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Lung cancer metastatic | 0 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Nervous system disorders | 9 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Dizziness | 3 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Somnolence | 2 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Convulsion | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Syncope | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Psychiatric disorders | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Depression | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Skin and subcutaneous tissue disorders | 3 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Rash | 2 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Pruritus | 1 Participants |
| Oxycodone IR | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Headache | 2 Participants |
Secondary
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.
Time frame: Day 0 and Day 2
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | 80.1 Units on a Scale | Standard Error 4.34 |
| Oxycodone IR | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | 81.8 Units on a Scale | Standard Error 4.26 |
p-value: 0.769195% CI: [-10.1, 13.7]ANCOVA
Secondary
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.
Time frame: Day 0 and Day 5
Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NUCYNTA | Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days | 254.8 Units on a Scale | Standard Error 5.01 |
| Oxycodone IR | Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days | 256.4 Units on a Scale | Standard Error 4.91 |
p-value: 0.822695% CI: [-12.2, 15.4]ANCOVA