A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee
Saol Therapeutics Inc
Summary
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.
Description
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.
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria includes: 1. Male or female patients ≥ 40 years of age 2. Body Mass Index (BMI) limits 3. Chronic knee pain resulting from osteoarthritis 4. Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) 5. Baseline KOOS pain 6. Patients taking baseline analgesics 7. Diagnostic nerve block response 8. Compliance with identified study requirements Exclusion Criteria includes: 1. Non-OA inflammatory arthritis 2. Confounding elements 3. Lower limb amputation. 4. Specified alternate historic treatments 5. Identified underlying physiologic or psychosocial conditions 6. Patient Health…
Interventions
- DrugSL1002
SL1002 injectable solution
- DrugNormal Saline
Normal Saline
Locations (18)
- Innovative Pain Treatment SolutionsSan Diego, California
- DBPS Research, LLCGreenwood Village, Colorado
- International Spine, Pain & Performance CenterWashington D.C., District of Columbia
- Prime Medical ResearchCoral Gables, Florida
- Conquest Research, LLCOrlando, Florida
- Conquest Research, LLCWinter Park, Florida