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Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain (COMPASS)

About the study

If you suffer from chronic pain or aching in your knee, you may have osteoarthritis (OA) – a painful joint condition that can interfere with all aspects of daily life. When initial treatments fail to relieve the pain, many sufferers are faced with an unsettling future – increasing use of pain medications, invasive knee surgery, or continued suffering.

If you’re living with chronic knee pain, you may qualify for a new clinical research study. The study is for an investigational injectable medication for chronic knee pain associated with OA. The study is currently being offered at select locations throughout the U.S.

If you qualify and choose to join the study, you will receive study-related care at no cost and will also be compensated up to $1,300 for your participation.

Why participate?

If you have chronic knee pain or have been diagnosed with knee osteoarthritis (OA), you may qualify for a new clinical research study. The study is for an investigational injectable medication for chronic knee pain associated with OA. The study is being conducted under an FDA-authorized clinical study. If you qualify and choose to join the study, you will receive:

See if you qualify.

https://www.saolkneeoastudy.com

 

Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain (COMPASS)

https://clinicaltrials.gov/ct2/show/NCT05470608

Brief Summary:

This is a multicenter, randomized, double-blind, placebo-controlled, single ascending dose escalation study to assess the safety and efficacy of single treatment exposure of an injectable formulation of SL-1002 for the treatment of knee pain associated with osteoarthritis. Phase A of the study will enroll 3 cohorts of 8 patients per cohort, for a total of 24 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio within each given cohort. Phase B of the study will enroll a minimum of 92 up to a maximum of 108 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio at the recommended dose determined from Phase A. The study period will be up to 168 days inclusive of a screening period of up to 28 days.

Principal Investigator: J. Scott Bainbridge, MD

Sub-investigators: Drew Trainor, DO, Ajay Vellore, MD, Susie Estes, NP

Sponsor: SAOL Therapeutics

Status: Currently enrolling patients into phase B

Condition: Chronic knee pain due to osteoarthritis (OA)