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

RecruitingPhase 3

Sponsor: Saol Therapeutics Inc

Conditions: Osteoarthritis Knee Pain

Interventions: SL1002, Normal Saline

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 Questionnaire
7. Moderate to severe hepatic impairment
8. Moderate to severe renal impairment
9. Identifiable baseline medications
10. Protocol compliance requirements
11. Known allergies or hypersensitivity to identified agents
12. Identified alcohol or drug abuse history
13. Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
14. Identified underlying abnormal laboratory results

Locations (21)

Roseville, California, United States
San Diego, California, United States
Greenwood Village, Colorado, United States
Washington D.C., District of Columbia, United States
Coral Gables, Florida, United States
Orlando, Florida, United States
Winter Park, Florida, United States
Rochester, Minnesota, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Edmond, Oklahoma, United States
Eugene, Oregon, United States
Altoona, Pennsylvania, United States
Sewickley, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Bellaire, Texas, United States
Corpus Christi, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States