Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
Recruiting · NCT07226258 · Interventional (participants receive a specific treatment) · Lead sponsor: Saol Therapeutics Inc
View the official record on ClinicalTrials.gov →Interventions studied
Normal SalineSL1002
What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
22 locations listed across 13 US states.
- Sutter Neurology and Pain Management - Roseville, California, United States
- Innovative Pain Treatment Solutions - San Diego, California, United States
- DBPS Research, LLC - Greenwood Village, Colorado, United States
- International Spine, Pain & Performance Center - Washington D.C., District of Columbia, United States
- Prime Medical Research - Coral Gables, Florida, United States
- Conquest Research, LLC - Orlando, Florida, United States
- Interventional Pain Institute - The Villages, Florida, United States
- Conquest Research, LLC - Winter Park, Florida, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Queen City Clinical Research, PLLC - Charlotte, North Carolina, United States
- The Center for Clinical Research - Winston-Salem, North Carolina, United States
- Comprehensive Specialty Care - Edmond, Oklahoma, United States
- Pacific Sports and Spine - Eugene, Oregon, United States
- University Orthopedics Center - Altoona, Pennsylvania, United States
- Pain Diagnostics & Interventional Care LLC - Sewickley, Pennsylvania, United States
- Medical University of South Carolina (MUSC) - Charleston, South Carolina, United States
- PCPMG Clinical Research Unit, LLC - Greenville, South Carolina, United States
- Legent Orthopedic and Spine Hospital - Bellaire, Texas, United States
- Institute of Precision Pain Medicine - Corpus Christi, Texas, United States
- International Spine, Pain & Performance Center (IPP) - Tyler, Texas, United States
- University of Utah Orthopedic Center - Salt Lake City, Utah, United States
- Virginia iSpine Physicians, PC - Richmond, Virginia, United States