A Phase 3 interventional study of NKTR-181 BID tablets in Low Back Pain and Chronic Pain, sponsored by Nektar Therapeutics. Completed at 56 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by Nektar Therapeutics · Phase 3, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 638 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Nektar Therapeutics is the lead sponsor of 39 studies on the registry; 2 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NKTR-181 twice daily (BID) tablets
Drug: NKTR-181 BID tablets
NKTR-181 tablets 100-600 mg twice daily (BID)
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
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
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
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.
| Milestone | NKTR-181 |
|---|---|
| Started | 638 |
| Completed | 402 |
| Not completed | 236 |
Count of subjects reporting treatment emergent adverse events
| Participants | Rollover NKTR-181 | Rollover PBO | De Novo Opioid Experienced | De Novo Naive |
|---|---|---|---|---|
| Number of Participants Reporting Adverse Events | 138 | 151 | 110 | 62 |
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.
| Scores on a scale | Rollover NKTR-181 | Rollover PBO | De Novo Opioid Experienced | De Novo Naive |
|---|---|---|---|---|
| Pain Intensity: Baseline | 3.57 ± 1.968 | 4.11 ± 2.112 | 5.91 ± 1.749 | 6.18 ± 1.459 |
| Pain Intensity: Change from Baseline to Day 1 | -1.22 ± 2.109 | -1.71 ± 2.212 | -2.19 ± 2.009 | -2.66 ± 1.808 |
| Pain Intensity: Change from Baseline to Day 30 | -1.02 ± 2.233 | -1.40 ± 2.314 | -2.26 ± 2.134 | -2.26 ± 2.068 |
| Pain Intensity: Change from Baseline to Day 60 | -1.28 ± 2.037 | -1.58 ± 2.172 | -2.01 ± 2.000 | -2.49 ± 1.966 |
| Pain Intensity: Change from Baseline to Day 90 | -1.31 ± 2.142 | -1.48 ± 2.278 | -2.06 ± 1.932 | -2.38 ± 2.115 |
| Pain Intensity: Change from Baseline to Day 120 | -1.24 ± 2.269 | -1.44 ± 2.267 | -2.04 ± 1.933 | -2.58 ± 1.874 |
| Pain Intensity: Change from Baseline to Day 150 | -1.28 ± 2.116 | -1.54 ± 2.319 | -2.09 ± 2.016 | -2.44 ± 2.323 |
| Pain Intensity: Change from Baseline to Day 180 | -1.37 ± 2.103 | -1.49 ± 2.425 | -1.87 ± 2.053 | -2.80 ± 2.173 |
| Pain Intensity: Change from Baseline to Day 210 | -1.28 ± 2.131 | -1.58 ± 2.220 | -2.06 ± 1.944 | -3.01 ± 2.258 |
| Pain Intensity: Change from Baseline to Day 240 | -1.15 ± 1.837 | -1.82 ± 2.190 | -2.21 ± 1.908 | -2.84 ± 2.289 |
| Pain Intensity: Change from Baseline to Day 270 | -1.45 ± 2.154 | -1.62 ± 2.366 | -1.83 ± 1.915 | -2.65 ± 1.933 |
| Pain Intensity: Change from Baseline to Day 300 | -1.09 ± 2.149 | -1.48 ± 2.303 | -2.08 ± 2.144 | -2.31 ± 2.043 |
| Pain Intensity: Change from Baseline to Day 364 | -0.78 ± 2.175 | -1.31 ± 2.520 | -1.20 ± 2.102 | -2.15 ± 2.055 |
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.
| Scores on a scale | Rollover NKTR-181 | Rollover PBO | De Novo Opioid Experienced | De Novo Naive |
|---|---|---|---|---|
| Pain Interference: Baseline | 2.91 ± 2.205 | 3.25 ± 2.281 | 5.41 ± 2.298 | 5.44 ± 1.957 |
| Pain Interference: Change from Baseline to Day 1 | -1.23 ± 2.301 | -1.52 ± 2.163 | -2.34 ± 2.175 | -2.71 ± 2.169 |
| Pain Interference: Change from Baseline to Day 30 | -1.07 ± 2.070 | -1.29 ± 2.340 | -2.51 ± 2.583 | -2.17 ± 2.679 |
| Pain Interference: Change from Baseline to Day 60 | -1.17 ± 2.070 | -1.32 ± 2.104 | -2.18 ± 2.350 | -2.38 ± 2.277 |
| Pain Interference: Change from Baseline to Day 90 | -1.24 ± 2.344 | -1.34 ± 2.222 | -2.15 ± 2.447 | -2.11 ± 2.179 |
| Pain Interference: Change from Baseline to Day 120 | -1.31 ± 2.389 | -1.36 ± 2.309 | -2.33 ± 2.299 | -2.48 ± 2.173 |
| Pain Interference: Change from Baseline to Day 150 | -1.12 ± 2.329 | -1.22 ± 2.500 | -2.26 ± 2.372 | -2.16 ± 2.290 |
| Pain Interference: Change from Baseline to Day 180 | -1.31 ± 2.247 | -1.33 ± 2.507 | -2.09 ± 2.551 | -2.27 ± 2.404 |
| Pain Interference: Change from Baseline to Day 210 | -0.95 ± 2.325 | -1.29 ± 2.215 | -2.43 ± 2.365 | -2.38 ± 2.611 |
| Pain Interference: Change from Baseline to Day 240 | -0.95 ± 2.119 | -1.55 ± 2.197 | -2.49 ± 2.503 | -2.27 ± 2.240 |
| Pain Interference: Change from Baseline to Day 270 | -1.21 ± 2.339 | -1.37 ± 2.329 | -2.02 ± 2.374 | -2.01 ± 2.193 |
| Pain Interference: Change from Baseline to Day 300 | -0.90 ± 2.307 | -1.38 ± 2.137 | -2.07 ± 2.280 | -1.94 ± 2.357 |
| Pain Interference: Change from Baseline to Day 364 | -0.69 ± 2.258 | -1.14 ± 2.493 | -1.33 ± 2.396 | -2.08 ± 2.504 |
Collected over Adverse events were reported starting immediately after the subject provided written informed consent through the end of study, which was approximately 57-weeks in length for each subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rollover NKTR-181 | 0/214 (0%) | 10/214 (4.7%) | 136/214 (63.6%) |
| Rollover PBO | 0/217 (0%) | 8/217 (3.7%) | 151/217 (69.6%) |
| De Novo Opioid Experienced | 0/134 (0%) | 8/134 (6%) | 110/134 (82.1%) |
| De Novo Naive | 0/73 (0%) | 4/73 (5.5%) | 62/73 (84.9%) |
| Event | Rollover NKTR-181 | Rollover PBO | De Novo Opioid Experienced | De Novo Naive |
|---|---|---|---|---|
| DuodenitisGastrointestinal disorders | 0/214 | 0/217 | 0/134 | 1/73 |
| PancreatitisGastrointestinal disorders | 0/214 | 0/217 | 0/134 | 1/73 |
| Generalized OedemaGeneral disorders | 0/214 | 0/217 | 0/134 | 1/73 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/214 | 0/217 | 0/134 | 1/73 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 0/214 | 0/217 | 0/134 | 1/73 |
| GoitreEndocrine disorders | 0/214 | 0/217 | 1/134 | 0/73 |
| Duodenal ulcerGastrointestinal disorders | 0/214 | 0/217 | 1/134 | 0/73 |
| Gastric ulcerGastrointestinal disorders | 0/214 | 0/217 | 1/134 | 0/73 |
| GastroenteritisInfections and infestations | 1/214 | 0/217 | 1/134 | 0/73 |
| PneumoniaInfections and infestations | 0/214 | 1/217 | 1/134 | 0/73 |
| Event | Rollover NKTR-181 | Rollover PBO | De Novo Opioid Experienced | De Novo Naive |
|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 28/214 | 41/217 | 56/134 | 41/73 |
| NauseaGastrointestinal disorders | 17/214 | 21/217 | 17/134 | 21/73 |
| HeadacheNervous system disorders | 9/214 | 21/217 | 21/134 | 6/73 |
| VomitingGastrointestinal disorders | 13/214 | 10/217 | 3/134 | 9/73 |
| DiarrhoeaGastrointestinal disorders | 6/214 | 11/217 | 4/134 | 8/73 |
| Upper respiratory tract infectionInfections and infestations | 12/214 | 19/217 | 10/134 | 7/73 |
| Urinary tract infectionInfections and infestations | 10/214 | 14/217 | 5/134 | 6/73 |
| PruritisSkin and subcutaneous tissue disorders | 4/214 | 5/217 | 6/134 | 6/73 |
| Drug withdrawalGeneral disorders | 10/214 | 16/217 | 10/134 | 2/73 |
| InfluenzaInfections and infestations | 5/214 | 10/217 | 4/134 | 5/73 |
Safety Analysis Set is defined as all enrolled subjects who received at least 1 dose of study drug.
| Age, Continuous(Years) | Rollover NKTR-181 | Rollover PBO | De Novo Naive | De Novo Opioid Experienced | Total |
|---|---|---|---|---|---|
| Mean | 51.7 ± 12.01 | 51.4 ± 12.31 | 51.9 ± 10.44 | 55.6 ± 11.12 | 52.4 ± 11.85 |
| Sex: Female, Male(Participants) | Rollover NKTR-181 | Rollover PBO | De Novo Naive | De Novo Opioid Experienced | Total |
|---|---|---|---|---|---|
| Female | 123 | 126 | 44 | 82 | 375 |
| Male | 91 | 91 | 29 | 52 | 263 |
| Race (NIH/OMB)(Participants) | Rollover NKTR-181 | Rollover PBO | De Novo Naive | De Novo Opioid Experienced | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 2 | 0 | 1 | 6 |
| Asian | 2 | 2 | 1 | 0 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 0 | 1 |
| Black or African American | 71 | 70 | 19 | 24 | 184 |
| White | 136 | 138 | 51 | 106 | 431 |
| More than one race | 0 | 1 | 1 | 1 | 3 |
| Unknown or Not Reported | 2 | 3 | 1 | 2 | 8 |
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Nektar Therapeutics