Clinical trial · Interventional
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain
NCT02367820CI-TRIAL-00052386SUMMIT-LTScompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
| Low Back Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NKTR-181 BID tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NKTR-181
- description
- NKTR-181 twice daily (BID) tablets
- interventionNames
- Drug: NKTR-181 BID tablets
Primary outcomes (1)
- measure
- Number of Participants Reporting Adverse Events
- timeFrame
- Screening baseline through end of study, an average of 57 weeks
- description
- Count of subjects reporting treatment emergent adverse events
Secondary outcomes (2)
- measure
- Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52
- timeFrame
- Baseline, monthly change from baseline till the end of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDGudin J, Rauck R, Argoff C, Agaiby E, Gimbel J, Katz N, Doberstein SK, Tagliaferri M, Tagliaferri M, Potts J, Wild J, Lu L, Siddhanti S, Hale M, Markman J. Long-term Safety and Tolerability of NKTR-181 in Patients with Moderate to Severe Chronic Low Back Pain or Chronic Noncancer Pain: A Phase 3 Multicenter, Open-Label, 52-Week Study (SUMMIT-08 LTS). Pain Med. 2020 Nov 7;21(7):1347-1356. doi: 10.1093/pm/pnz169. PMID 31361019
- DERIVEDPark EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. PMID 30957581