Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
Part of paid clinical trials in San Diego, California.
- Sponsor
- Saol Therapeutics Inc
- Study ID
- NCT07226258
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Osteoarthritis Knee Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SL1002 — DRUGSL1002 injectable solution
- Normal Saline — DRUGNormal Saline
Study Details
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.
Key Dates
- Start date
- Nov 7, 2025
- Status verified
- May 2026
- Primary completion
- Nov 30, 2026
- Completion
- Feb 28, 2027
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: SL1002SL1002
- Placebo Comparator: PlaceboNormal saline
Primary Outcome Measure
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking [ Time Frame: Baseline to week 12 ]
Central Contacts
- Kiki Diorgu, M.D.770-274-2827
Locations (20)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Innovative Pain Treatment Solutions | San Diego | California | 92111 | Krishnan Chakravarthy, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR) |
| DBPS Research, LLC | Greenwood Village | Colorado | 80111 | Scott Bainbridge, M.D. (PRINCIPAL_INVESTIGATOR) |
| International Spine, Pain & Performance Center | Washington D.C. | District of Columbia | 20006 | Mehul Desai, M.D. (PRINCIPAL_INVESTIGATOR) |
| Prime Medical Research | Coral Gables | Florida | 33134 | Miguel Telleria, M.D. (PRINCIPAL_INVESTIGATOR) |
| Conquest Research, LLC | Orlando | Florida | 32832 | Jorge Fernandez-Silva, M.D. (PRINCIPAL_INVESTIGATOR) |
| Conquest Research, LLC | Winter Park | Florida | 32789 | Anand Patel, M.D. (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | Ryan D'Souza, M.D. (PRINCIPAL_INVESTIGATOR) |
| Queen City Clinical Research, PLLC | Charlotte | North Carolina | 28211 | Christopher Gilmore, M.D. (PRINCIPAL_INVESTIGATOR) |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | Leonardo Kapural, M.D. (PRINCIPAL_INVESTIGATOR) |
| Comprehensive Specialty Care | Edmond | Oklahoma | 73034 | Douglas Beall, M.D. (PRINCIPAL_INVESTIGATOR) |
| Pacific Sports and Spine | Eugene | Oregon | 97404 | Gregory Moore, M.D. (PRINCIPAL_INVESTIGATOR) |
| University Orthopedics Center | Altoona | Pennsylvania | 16602 | Fred Khalouf, D.O. (PRINCIPAL_INVESTIGATOR) |
| Pain Diagnostics & Interventional Care LLC | Sewickley | Pennsylvania | 15143 | David Provenzano, M.D. (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | Ameet Nagpal, M.D. (PRINCIPAL_INVESTIGATOR) |
| PCPMG Clinical Research Unit, LLC | Greenville | South Carolina | 29601 | Brian Jakubowicz, M.D. (PRINCIPAL_INVESTIGATOR) |
| Legent Orthopedic and Spine Hospital | Bellaire | Texas | 77401 | Daneshvari Solanki, M.D. (PRINCIPAL_INVESTIGATOR) |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | 78414 | Mitchell Engle, M.D. (PRINCIPAL_INVESTIGATOR) |
| International Spine, Pain & Performance Center (IPP) | Tyler | Texas | 75701 | Aaron Calodney, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Utah Orthopedic Center | Salt Lake City | Utah | 84108 | Zachary McCormick, M.D. (PRINCIPAL_INVESTIGATOR) |
| Virginia iSpine Physicians, PC | Richmond | Virginia | 23238 | Michael DePalma, M.D. (PRINCIPAL_INVESTIGATOR) |