Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nektar Therapeutics

Criteria

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