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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07226258). StuddyBuddy aggregates publicly available trial information.