This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.
Protocol No: TLC599A2003 Name of Finished Product: TLC599 Title of Study: A Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study for Single dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee. Study duration: The trial will last around 27 weeks including a 21-day screening period and a 24-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Single dose via intra-articular injection
Single dose via intra-articular injection
Single dose via intra-articular injection
Genesis Research Services Pty Limited
Broadmeadow, Australia
Pendlebury Clinic Private Hospital
Cardiff, Australia
Footscray Hospital- Western Health
Footscray, Australia
Change From Baseline in WOMAC Pain Subscale at Week 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale. Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome). Missing data were imputed.
Time frame: Baseline, Week 12
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Linear Clinical Research Limited
Nedlands, Australia
Royal North Shore Hospital
Sydney, Australia
Show Chwan Memorial Hospital
Changhua, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Chung Shan Medical University Hosptial
Taichung, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
...and 3 more locations