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Keep this study
Lead
Nektar Therapeutics
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
