Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02367820 | Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain | PHASE3 | COMPLETED | 638 | — | — | Apr 14, 2015 | Jan 1, 2018 | Jun 22, 2021 | 56 | United States |
| NCT02362672 | Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain | PHASE3 | COMPLETED | 1,189 | — | — | Mar 11, 2015 | Feb 1, 2017 | Sep 16, 2020 | 54 | United States |
Count of subjects reporting treatment emergent adverse events
The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
| Arm | Type | Description |
|---|---|---|
| NKTR-181 | EXPERIMENTAL | NKTR-181 twice daily (BID) tablets |
| Placebo | PLACEBO_COMPARATOR | Placebo to match NKTR-181 twice daily (BID) tablets |
| Name | Type | Description |
|---|---|---|
| NKTR-181 BID tablets | DRUG | NKTR-181 tablets 100-600 mg twice daily (BID) |
| Placebo to match NKTR-181 BID tablets | DRUG | Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID) |
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 * Opi...