The Excellence study looks at the safety of a new injectable investigational medication and how effective it may be in treating the pain, inflammation and mobility symptoms of osteoarthritis (OA) in the knee. The medication we are investigating is called TLC599.
TLC599 is an investigational slow-release formulation of dexamethasone sodium phosphate (DSP), which is an approved corticosteroid for treating OA symptoms. While DSP can be effective at treating OA symptoms, relief can often last only two to four weeks. This study is being conducted to find out if TLC599 can have longer-lasting effects on OA symptoms.
Qualified participants will receive up to two injections of study treatment. Study staff will administer the first injection at the participant’s second study visit. The second injection will be administered to those participants who continue to qualify about 24 weeks after the first injection.
Participant eligibility criteria:
- Be at least 40 years old;
- Have been diagnosed with knee OA and suffer moderate pain due to osteoarthritis for at least six months;
- Not have recently had injections (cortisone, hyaluronic acid, PRP) or surgery for the knee (arthroscopy or replacement);
- And be able to attend Royal North Shore Hospital for up to 19 short appointments during the 56 weeks trial including 4 weeks screening period.
You will not have to pay for the study medication or any study-related procedures and examinations. Reimbursement may be provided for travel.
This study has been approved by the Northern Sydney Local Health District Human Research Ethics Committee, Reference No. 2019/ETH13673