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

Date Added
November 12th, 2025
PRO Number
Pro00147576
Researcher
Ameet Nagpal

List of Studies

Keywords
Arthritis, Pain
Summary

The purpose of this phase III study is to assess the safety and efficacy of the SL-1002 injectable formulation, compared to placebo, for the treatment of knee pain associated with osteoarthritis, which is not currently approved by the FDA. This study will last approximately 26 weeks, which includes a screening period that includes 1 or 2 visits. Eligible subjects will undergo a 1:1 randomization with the SL 1002 formula or normal saline used as a placebo. After the screening visits and the study drug treatment visit (Day 1), the subject will be required to return to the study site for 5 additional study visits at approximately 1,2,3,4, and 6 months after the study drug treatment (Day 1). These visits will include physical examinations, knee assessments, patient questionnaires, and the collection of vital signs, and blood and urine samples. This study also requires daily electronic data entries from Day 1 to the end of the study.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu



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