Summary:
Arizona Research Center is conducting a Phase 3 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain.
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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
- More Inclusion Criteria Apply
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
- More exclusion criteria apply
Qualified Participants May Receive:
$45 per each completed visit (up to 20 office visits over study period).