Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
CompletedPhase 3NCT02367820
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: NKTR-181 BID tablets
- Sponsor
- Nektar Therapeutics
- Start date
- 2015-04-14
- Primary completion
- 2017-12
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 56
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02367820