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| Name | Class |
|---|---|
| Lotus Clinical Research, LLC | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine Micropellets | Active Comparator | single dose injection into the lumbar epidural space |
|
| Sham Control | Sham Comparator | non-epidural needle placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine Micropellets | Combination Product | Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to day 30 |
| Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Gilligan, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sollis Clinical Study Site 36 | Mobile | Alabama | 36605 | United States | ||
| Sollis Clinical Study Site #41 |
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Clonidine Micropellet vs Sham-Control
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Double-Blinded
| Sham |
| Other |
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. |
| 1 day post injection |
| Difference in Rescue medication consumption | Consumption from baseline through day 30 | Baseline to day 30 |
| Percent of subjects with significant improvement in pain | 50 percent improvement in pain from baseline to day 30 | Baseline to day 30 |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Sollis Clinical Study Site #44 | Phoenix | Arizona | 85053 | United States |
| Sollis Clinical Study Site 29 | Scottsdale | Arizona | 85258 | United States |
| Sollis Clinical Study Site 40 | Tucson | Arizona | 85724 | United States |
| Sollis Clinical Study Site 49 | Rancho Mirage | California | 92270 | United States |
| Sollis Clinical Study Site 28 | Santa Rosa | California | 95401 | United States |
| Sollis Clinical Study Site 30 | Washington D.C. | District of Columbia | 22205 | United States |
| Sollis Clinical Study Site 35 | Fort Lauderdale | Florida | 33316 | United States |
| Sollis Clinical Study Site 38 | Miami | Florida | 33135 | United States |
| Sollis Clinical Study Site 12 | Bloomington | Illinois | 61704 | United States |
| Sollis Clinical Study Site 13 | Chicago | Illinois | 60657 | United States |
| Sollis Clinical Study Site 14 | Kansas City | Kansas | 66160 | United States |
| Sollis Clinical Study Site | Overland Park | Kansas | 66210 | United States |
| Sollis Clinical Study Site 10 | Edgewood | Kentucky | 41017 | United States |
| Sollis Clinical Study Site 16 | Boston | Massachusetts | 02115 | United States |
| Sollis Clinical Study Site 15 | Brookline | Massachusetts | 02445 | United States |
| Sollis Clinical Study Site 17 | Shrewsbury | New Jersey | 60657 | United States |
| Sollis Clinical Study Site 25 | Albany | New York | 12208 | United States |
| Sollis Clinical Study Site 31 | Rochester | New York | 14620 | United States |
| Sollis Clinical Study Site 18 | Winston-Salem | North Carolina | 27103 | United States |
| Sollis Clinical Study Site 21 | Cleveland | Ohio | 44106 | United States |
| Sollis Clinical Study Site 33 | Cleveland | Ohio | 44195 | United States |
| Sollis Clinical Study Site 19 | Edmond | Oklahoma | 73013 | United States |
| Sollis Clinical Study Site 46 | Eugene | Oregon | 97401 | United States |
| Sollis Clinical Study Site | Dallas | Texas | 75240 | United States |
| Sollis Clinical Study Site 34 | Houston | Texas | 77004 | United States |
| Sollis Clinical Study Site 22 | San Antonio | Texas | 78229 | United States |
| Sollis Clinical Study Site 43 | The Woodlands | Texas | 77382 | United States |
| Sollis Clinical Study Site 20 | Tyler | Texas | 75701 | United States |
| Sollis Clinical Study Site 47 | Salt Lake City | Utah | 84107 | United States |
| Sollis Clinical Study Site 23 | Morgantown | West Virginia | 26505 | United States |
| Sollis Clinical Study Site 27 | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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