Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
Purpose
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.
Condition
- Osteoarthritis Knee Pain
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SL1002 |
SL1002 |
|
|
Placebo Comparator Placebo |
Normal saline |
|
Recruiting Locations
San Diego, California 92111
Greenwood Village, Colorado 80111
Washington D.C., District of Columbia 20006
Coral Gables, Florida 33134
Orlando, Florida 32832
Winter Park, Florida 32789
Charlotte, North Carolina 28211
Winston-Salem, North Carolina 27103
Edmond, Oklahoma 73034
Eugene, Oregon 97404
Altoona, Pennsylvania 16602
Sewickley, Pennsylvania 15143
Charleston, South Carolina 29425
Greenville, South Carolina 29601
Bellaire, Texas 77401
Corpus Christi, Texas 78414
Tyler, Texas 75701
Salt Lake City, Utah 84108
Richmond, Virginia 23238
More Details
- Status
- Recruiting
- Sponsor
- Saol Therapeutics Inc
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.