Clinical Trials

Study Title

NK-181-07

Purpose

To assess the the analgesic effect of NKTR-181 in subjects with moderate to severe chronic low back

Eligibility

Opioid-Naïve Subjects with Moderate to Severe Chronic Low Back Pain

Study Process

Patients age 18-75 with chronic low back pain will be enrolled into the study with two periods.  The first period is an open-label titiration phase (no placebo) followed by a 12 week double blind randomized period (patients will be randomly assigned to receive study medication or placebo).  Patients completing the study will be offered the opportunity to then participate in the 08 study which is an open label treatment study without the use of placebo for 54 weeks.