A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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
Locations
United States
Colorado
DBPS Research, LLC
RECRUITING
Greenwood Village
Washington, D.c.
International Spine, Pain & Performance Center
RECRUITING
Washington D.c.
Florida
Prime Medical Research
RECRUITING
Coral Gables
Conquest Research, LLC
RECRUITING
Orlando
Conquest Research, LLC
RECRUITING
Winter Park
North Carolina
Queen City Clinical Research, PLLC
RECRUITING
Charlotte
The Center for Clinical Research
RECRUITING
Winston-salem
Oregon
Pacific Sports and Spine
RECRUITING
Eugene
Pennsylvania
University Orthopedics Center
RECRUITING
Altoona
South Carolina
PCPMG Clinical Research Unit, LLC
RECRUITING
Greenville
Texas
HD Research, First Surgical Hospital (FSH)
RECRUITING
Bellaire
Institute of Precision Pain Medicine
RECRUITING
Corpus Christi
Virginia
Virginia iSpine Physicians, PC
RECRUITING
Richmond
Contact Information
Primary
Kiki Diorgu, M.D.
info@saolrx.com
770-274-2827
Time Frame
Start Date: 2025-11-07
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 150
Treatments
Experimental: SL1002
SL1002
Placebo_comparator: Placebo
Normal saline
Related Therapeutic Areas
Sponsors
Leads: Saol Therapeutics Inc