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A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the treatment of knee pain associated with mild to moderate osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SL1002 | Experimental | SL1002 |
|
| Placebo | Placebo Comparator | Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SL1002 | Drug | SL1002 injectable solution |
| |
| Normal Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking | The pain intensity score is measured using a numeric rating scale (NRS) | Baseline to week 12 |
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Inclusion Criteria includes:
Exclusion Criteria includes:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kiki Diorgu, M.D. | Contact | 770-274-2827 | info@saolrx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter Neurology and Pain Management | Recruiting | Roseville | California | 95661 | United States |
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| Drug |
Normal Saline |
|
| Innovative Pain Treatment Solutions | Recruiting | San Diego | California | 92111 | United States |
|
| DBPS Research, LLC | Recruiting | Greenwood Village | Colorado | 80111 | United States |
|
| International Spine, Pain & Performance Center | Recruiting | Washington D.C. | District of Columbia | 20006 | United States |
|
| Prime Medical Research | Recruiting | Coral Gables | Florida | 33134 | United States |
|
| Conquest Research, LLC | Recruiting | Orlando | Florida | 32832 | United States |
|
| Conquest Research, LLC | Recruiting | Winter Park | Florida | 32789 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Queen City Clinical Research, PLLC | Recruiting | Charlotte | North Carolina | 28211 | United States |
|
| The Center for Clinical Research | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
|
| Comprehensive Specialty Care | Recruiting | Edmond | Oklahoma | 73034 | United States |
|
| Pacific Sports and Spine | Recruiting | Eugene | Oregon | 97404 | United States |
|
| University Orthopedics Center | Recruiting | Altoona | Pennsylvania | 16602 | United States |
|
| Pain Diagnostics & Interventional Care LLC | Recruiting | Sewickley | Pennsylvania | 15143 | United States |
|
| Medical University of South Carolina (MUSC) | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| PCPMG Clinical Research Unit, LLC | Recruiting | Greenville | South Carolina | 29601 | United States |
|
| Legent Orthopedic and Spine Hospital | Recruiting | Bellaire | Texas | 77401 | United States |
|
| Institute of Precision Pain Medicine | Recruiting | Corpus Christi | Texas | 78414 | United States |
|
| International Spine, Pain & Performance Center (IPP) | Recruiting | Tyler | Texas | 75701 | United States |
|
| University of Utah Orthopedic Center | Recruiting | Salt Lake City | Utah | 84108 | United States |
|
| Virginia iSpine Physicians, PC | Recruiting | Richmond | Virginia | 23238 | United States |
|
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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