Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain

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.

Inclusion criteria

includes:

• Male or female patients ≥ 40 years of age
• Body Mass Index (BMI) limits
• Chronic knee pain resulting from osteoarthritis
• Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)
• Baseline KOOS pain
• Patients taking baseline analgesics
• Diagnostic nerve block response
• Compliance with identified study requirements

Exclusion criteria

includes:

• Non-OA inflammatory arthritis
• Confounding elements
• Lower limb amputation.
• Specified alternate historic treatments
• Identified underlying physiologic or psychosocial conditions
• Patient Health Questionnaire
• Moderate to severe hepatic impairment
• Moderate to severe renal impairment
• Identifiable baseline medications
• Protocol compliance requirements
• Known allergies or hypersensitivity to identified agents
• Identified alcohol or drug abuse history
• Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
• Identified underlying abnormal laboratory results