Chronic Pain, Low Back Pain
Conditions
Brief summary
The purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.
Detailed description
This is an open-label safety and tolerability study in which approximately 600 subjects will receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and subjects who have recently completed SUMMIT-07 study. This study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic low back pain or chronic non-cancer pain.
Interventions
NKTR-181 tablets 100-600 mg twice daily (BID)
Sponsors
Nektar Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant, non-nursing female aged 18 to 75 years old * Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months * Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics * Opioid analgesia is necessary * Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry * Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug. * Willing and able to provide informed consent
Exclusion criteria
* History of hypersensitivity, intolerance, or allergy to opioids * Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period * Untreated moderate to severe sleep apnea * Chronic migraines as the primary pain condition * Cancer related pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Adverse Events | Screening baseline through end of study, an average of 57 weeks | Count of subjects reporting treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Baseline, monthly change from baseline till the end of study | A self-reported scale measuring severity of pain on function. The mean of the 4 intensity items (3-6) is calculated and used as a measure of pain severity. If there were missing items when the pain severity score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain intensity and interference for each question is from 0 to 10. The range of possible scores is from 0 to 70. Higher score indicates relatively worse pain severity and greater interference that pain causes in day to day activities. |
| Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Baseline, monthly change from baseline till the end of study | A self-reported scale measuring interference of pain on function. The mean of the 7 interference items was calculated and used as a measure of Pain interference. If there were missing items when the pain interference score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain interference is from 0 to 10. Higher score indicates relatively worse pain problem. |
Countries
United States
Participant flow
Recruitment details
First subject screened 14 April 2015. Last subject out: 24 January 2018. The study was conducted at 55 medical/research centers in the United States.
Pre-assignment details
The titration phase of the study was designed to titrate patients to a dose of NKTR-181 that provided adequate analgesia and acceptable side effects.
Participants by arm
| Arm | Count |
|---|---|
| Rollover NKTR-181 Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study | 214 |
| Rollover PBO Subjects administered placebo in preceding phase 3 efficacy/safety study | 217 |
| De Novo Naive Newly enrolled opioid naïve subjects | 73 |
| De Novo Opioid Experienced Newly enrolled opioid experienced subjects | 134 |
| Total | 638 |
Baseline characteristics
| Characteristic | Rollover NKTR-181 | Total | De Novo Opioid Experienced | De Novo Naive | Rollover PBO |
|---|---|---|---|---|---|
| Age, Continuous | 51.7 Years STANDARD_DEVIATION 12.01 | 52.4 Years STANDARD_DEVIATION 11.85 | 55.6 Years STANDARD_DEVIATION 11.12 | 51.9 Years STANDARD_DEVIATION 10.44 | 51.4 Years STANDARD_DEVIATION 12.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants | 184 Participants | 24 Participants | 19 Participants | 70 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 136 Participants | 431 Participants | 106 Participants | 51 Participants | 138 Participants |
| Sex: Female, Male Female | 123 Participants | 375 Participants | 82 Participants | 44 Participants | 126 Participants |
| Sex: Female, Male Male | 91 Participants | 263 Participants | 52 Participants | 29 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 214 | 0 / 217 | 0 / 134 | 0 / 73 |
| other Total, other adverse events | 136 / 214 | 151 / 217 | 110 / 134 | 62 / 73 |
| serious Total, serious adverse events | 10 / 214 | 8 / 217 | 8 / 134 | 4 / 73 |
Outcome results
Primary
Number of Participants Reporting Adverse Events
Count of subjects reporting treatment emergent adverse events
Time frame: Screening baseline through end of study, an average of 57 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rollover NKTR-181 | Number of Participants Reporting Adverse Events | 138 Participants |
| Rollover PBO | Number of Participants Reporting Adverse Events | 151 Participants |
| De Novo Opioid Experienced | Number of Participants Reporting Adverse Events | 110 Participants |
| De Novo Naive | Number of Participants Reporting Adverse Events | 62 Participants |
Secondary
Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52
A self-reported scale measuring severity of pain on function. The mean of the 4 intensity items (3-6) is calculated and used as a measure of pain severity. If there were missing items when the pain severity score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain intensity and interference for each question is from 0 to 10. The range of possible scores is from 0 to 70. Higher score indicates relatively worse pain severity and greater interference that pain causes in day to day activities.
Time frame: Baseline, monthly change from baseline till the end of study
Population: Safety Analysis Set is defined as all enrolled subjects who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 300 | -1.09 Scores on a scale | Standard Deviation 2.149 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 30 | -1.02 Scores on a scale | Standard Deviation 2.233 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 150 | -1.28 Scores on a scale | Standard Deviation 2.116 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 364 | -0.78 Scores on a scale | Standard Deviation 2.175 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Baseline | 3.57 Scores on a scale | Standard Deviation 1.968 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 60 | -1.28 Scores on a scale | Standard Deviation 2.037 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 210 | -1.28 Scores on a scale | Standard Deviation 2.131 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 270 | -1.45 Scores on a scale | Standard Deviation 2.154 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 90 | -1.31 Scores on a scale | Standard Deviation 2.142 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 1 | -1.22 Scores on a scale | Standard Deviation 2.109 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 240 | -1.15 Scores on a scale | Standard Deviation 1.837 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 180 | -1.37 Scores on a scale | Standard Deviation 2.103 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 120 | -1.24 Scores on a scale | Standard Deviation 2.269 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 120 | -1.44 Scores on a scale | Standard Deviation 2.267 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 210 | -1.58 Scores on a scale | Standard Deviation 2.22 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 150 | -1.54 Scores on a scale | Standard Deviation 2.319 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 300 | -1.48 Scores on a scale | Standard Deviation 2.303 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 180 | -1.49 Scores on a scale | Standard Deviation 2.425 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Baseline | 4.11 Scores on a scale | Standard Deviation 2.112 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 1 | -1.71 Scores on a scale | Standard Deviation 2.212 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 30 | -1.40 Scores on a scale | Standard Deviation 2.314 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 270 | -1.62 Scores on a scale | Standard Deviation 2.366 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 60 | -1.58 Scores on a scale | Standard Deviation 2.172 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 90 | -1.48 Scores on a scale | Standard Deviation 2.278 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 240 | -1.82 Scores on a scale | Standard Deviation 2.19 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 364 | -1.31 Scores on a scale | Standard Deviation 2.52 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 120 | -2.04 Scores on a scale | Standard Deviation 1.933 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 60 | -2.01 Scores on a scale | Standard Deviation 2 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 240 | -2.21 Scores on a scale | Standard Deviation 1.908 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 1 | -2.19 Scores on a scale | Standard Deviation 2.009 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 30 | -2.26 Scores on a scale | Standard Deviation 2.134 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 90 | -2.06 Scores on a scale | Standard Deviation 1.932 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Baseline | 5.91 Scores on a scale | Standard Deviation 1.749 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 150 | -2.09 Scores on a scale | Standard Deviation 2.016 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 180 | -1.87 Scores on a scale | Standard Deviation 2.053 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 210 | -2.06 Scores on a scale | Standard Deviation 1.944 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 270 | -1.83 Scores on a scale | Standard Deviation 1.915 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 300 | -2.08 Scores on a scale | Standard Deviation 2.144 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 364 | -1.20 Scores on a scale | Standard Deviation 2.102 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 90 | -2.38 Scores on a scale | Standard Deviation 2.115 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 240 | -2.84 Scores on a scale | Standard Deviation 2.289 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 60 | -2.49 Scores on a scale | Standard Deviation 1.966 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 30 | -2.26 Scores on a scale | Standard Deviation 2.068 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Baseline | 6.18 Scores on a scale | Standard Deviation 1.459 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 270 | -2.65 Scores on a scale | Standard Deviation 1.933 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 1 | -2.66 Scores on a scale | Standard Deviation 1.808 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 300 | -2.31 Scores on a scale | Standard Deviation 2.043 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 364 | -2.15 Scores on a scale | Standard Deviation 2.055 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 180 | -2.80 Scores on a scale | Standard Deviation 2.173 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 150 | -2.44 Scores on a scale | Standard Deviation 2.323 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 120 | -2.58 Scores on a scale | Standard Deviation 1.874 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 | Pain Intensity: Change from Baseline to Day 210 | -3.01 Scores on a scale | Standard Deviation 2.258 |
Secondary
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52
A self-reported scale measuring interference of pain on function. The mean of the 7 interference items was calculated and used as a measure of Pain interference. If there were missing items when the pain interference score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain interference is from 0 to 10. Higher score indicates relatively worse pain problem.
Time frame: Baseline, monthly change from baseline till the end of study
Population: Safety Analysis Set is defined as all enrolled subjects who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 30 | -1.07 Scores on a scale | Standard Deviation 2.07 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 1 | -1.23 Scores on a scale | Standard Deviation 2.301 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 300 | -0.90 Scores on a scale | Standard Deviation 2.307 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 270 | -1.21 Scores on a scale | Standard Deviation 2.339 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 120 | -1.31 Scores on a scale | Standard Deviation 2.389 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 240 | -0.95 Scores on a scale | Standard Deviation 2.119 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 210 | -0.95 Scores on a scale | Standard Deviation 2.325 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 180 | -1.31 Scores on a scale | Standard Deviation 2.247 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 150 | -1.12 Scores on a scale | Standard Deviation 2.329 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 90 | -1.24 Scores on a scale | Standard Deviation 2.344 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Baseline | 2.91 Scores on a scale | Standard Deviation 2.205 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 364 | -0.69 Scores on a scale | Standard Deviation 2.258 |
| Rollover NKTR-181 | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 60 | -1.17 Scores on a scale | Standard Deviation 2.07 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 364 | -1.14 Scores on a scale | Standard Deviation 2.493 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Baseline | 3.25 Scores on a scale | Standard Deviation 2.281 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 1 | -1.52 Scores on a scale | Standard Deviation 2.163 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 30 | -1.29 Scores on a scale | Standard Deviation 2.34 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 60 | -1.32 Scores on a scale | Standard Deviation 2.104 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 90 | -1.34 Scores on a scale | Standard Deviation 2.222 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 120 | -1.36 Scores on a scale | Standard Deviation 2.309 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 150 | -1.22 Scores on a scale | Standard Deviation 2.5 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 180 | -1.33 Scores on a scale | Standard Deviation 2.507 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 210 | -1.29 Scores on a scale | Standard Deviation 2.215 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 240 | -1.55 Scores on a scale | Standard Deviation 2.197 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 270 | -1.37 Scores on a scale | Standard Deviation 2.329 |
| Rollover PBO | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 300 | -1.38 Scores on a scale | Standard Deviation 2.137 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 150 | -2.26 Scores on a scale | Standard Deviation 2.372 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 120 | -2.33 Scores on a scale | Standard Deviation 2.299 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 240 | -2.49 Scores on a scale | Standard Deviation 2.503 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 270 | -2.02 Scores on a scale | Standard Deviation 2.374 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 1 | -2.34 Scores on a scale | Standard Deviation 2.175 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 364 | -1.33 Scores on a scale | Standard Deviation 2.396 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 30 | -2.51 Scores on a scale | Standard Deviation 2.583 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 180 | -2.09 Scores on a scale | Standard Deviation 2.551 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Baseline | 5.41 Scores on a scale | Standard Deviation 2.298 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 300 | -2.07 Scores on a scale | Standard Deviation 2.28 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 210 | -2.43 Scores on a scale | Standard Deviation 2.365 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 90 | -2.15 Scores on a scale | Standard Deviation 2.447 |
| De Novo Opioid Experienced | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 60 | -2.18 Scores on a scale | Standard Deviation 2.35 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 120 | -2.48 Scores on a scale | Standard Deviation 2.173 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 150 | -2.16 Scores on a scale | Standard Deviation 2.29 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 180 | -2.27 Scores on a scale | Standard Deviation 2.404 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 210 | -2.38 Scores on a scale | Standard Deviation 2.611 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 270 | -2.01 Scores on a scale | Standard Deviation 2.193 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 300 | -1.94 Scores on a scale | Standard Deviation 2.357 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 1 | -2.71 Scores on a scale | Standard Deviation 2.169 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Baseline | 5.44 Scores on a scale | Standard Deviation 1.957 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 240 | -2.27 Scores on a scale | Standard Deviation 2.24 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 30 | -2.17 Scores on a scale | Standard Deviation 2.679 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 90 | -2.11 Scores on a scale | Standard Deviation 2.179 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 60 | -2.38 Scores on a scale | Standard Deviation 2.277 |
| De Novo Naive | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 | Pain Interference: Change from Baseline to Day 364 | -2.08 Scores on a scale | Standard Deviation 2.504 |