Overview
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
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