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NCT07226258PHASE3Recruiting

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

Saol Therapeutics Inc

Start Date

11/7/2025

Completion Date

2/28/2027

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.

Detailed 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 Criteria

Age Range: 40 years to No maximum

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

Interventions

DRUG

SL1002

DRUG

Normal Saline

Interested in This Trial?

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Conditions

Osteoarthritis Knee Pain

Locations

Sutter Neurology and Pain Management

Roseville, California 95661

United States

Innovative Pain Treatment Solutions

San Diego, California 92111

United States

DBPS Research, LLC

Greenwood Village, Colorado 80111

United States

International Spine, Pain & Performance Center

Washington D.C., District of Columbia 20006

United States

Prime Medical Research

Coral Gables, Florida 33134

United States

Conquest Research, LLC

Orlando, Florida 32832

United States

Conquest Research, LLC

Winter Park, Florida 32789

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Queen City Clinical Research, PLLC

Charlotte, North Carolina 28211

United States

The Center for Clinical Research

Winston-Salem, North Carolina 27103

United States

Comprehensive Specialty Care

Edmond, Oklahoma 73034

United States

Pacific Sports and Spine

Eugene, Oregon 97404

United States

University Orthopedics Center

Altoona, Pennsylvania 16602

United States

Pain Diagnostics & Interventional Care LLC

Sewickley, Pennsylvania 15143

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina 29425

United States

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina 29601

United States

Legent Orthopedic and Spine Hospital

Bellaire, Texas 77401

United States

Institute of Precision Pain Medicine

Corpus Christi, Texas 78414

United States

International Spine, Pain & Performance Center (IPP)

Tyler, Texas 75701

United States

University of Utah Orthopedic Center

Salt Lake City, Utah 84108

United States

Virginia iSpine Physicians, PC

Richmond, Virginia 23238

United States