This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
207
Injection
Injection
Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from baseline to day 30.
Time frame: Baseline to day 60
Change in Oswestry Disability Index (ODI) score
6 categories of 10 question, each question is scored from 0-5 (minimum to maximum). The scores range from 0-100% with lower scores meaning less disability.
Time frame: Baseline to day 30
Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection.
Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from injection to 24 hrs post injection.
Time frame: 1 day post injection
Difference in Rescue medication consumption
Consumption from baseline through day 30
Time frame: Baseline to day 30
Percent of subjects with significant improvement in pain
50 percent improvement in pain from baseline to day 30
Time frame: Baseline to day 30
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Sollis Clinical Study Site 36
Mobile, Alabama, United States
Sollis Clinical Study Site #41
Phoenix, Arizona, United States
Sollis Clinical Study Site #44
Phoenix, Arizona, United States
Sollis Clinical Study Site 29
Scottsdale, Arizona, United States
Sollis Clinical Study Site 40
Tucson, Arizona, United States
Sollis Clinical Study Site 49
Rancho Mirage, California, United States
Sollis Clinical Study Site 28
Santa Rosa, California, United States
Sollis Clinical Study Site 30
Washington D.C., District of Columbia, United States
Sollis Clinical Study Site 35
Fort Lauderdale, Florida, United States
Sollis Clinical Study Site 38
Miami, Florida, United States
...and 23 more locations