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Active Not Recruiting
NCT07226258
Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
Conditions: Osteoarthritis Knee Pain
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 150
Sponsor: Saol Therapeutics Inc
Location: Sutter Neurology and Pain Management Roseville California
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.
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
Source: ClinicalTrials.gov (NCT07226258). StuddyBuddy aggregates publicly available trial information.