This study is a multi-center, randomized, placebo-controlled, double-blind clinical study, consisting of Part 1 (Phase 1b) in a sequential, dose-escalating design and Part 2 (Phase 2) in a parallel design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis
Emeritus Research
Camberwell, Australia
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point
Change of WOMAC (11-point NRS) pain score from baseline to Week 12 \- a total of 5 questions, each question's score is as below Mininum : 0 (no pain) Maximum : 10 (extreme pain) Higher score means worse outcome
Time frame: week 12
Change in WOMAC score from baseline to time point
Change of WOMAC (11-point NRS) score 1. WOMAC pain score (except week 12) 2. WOMAC function, stiffness, total score * function (17 questions, scores are 0 to 170) * stiffness (2 questions, scores are 0 to 20) * total score: pain + function + stiffness = 240 at maximum Higher score means worse outcome
Time frame: week 1 ~ week 24
Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point
Change in weekly mean of average daily pain intensity score (11-point NRS) \- 0 (no pain) to 10 (pain as bad as you can imagine)
Time frame: week 1 ~ week 24
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