Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.

• 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 non-neuropathic low back pain for at least six months

• Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics

• Opioid analgesia is necessary

• Currently taking no more than 10 mg morphine sulfate equivalents per day of short acting opioids for 14 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:

• Taking extended release or long-acting opioids within 6 months

• History of hypersensitivity, intolerance, or allergy to opioids

• Compression of spinal nerve root; spinal fracture, tumor, or abscess

• Surgical procedures on the low back in the last 12 months or facet nerve root block or radiofrequency ablation in the last 3 months

• Untreated moderate to severe sleep apnea