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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LG00034053 | Experimental | White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration |
|
| Placebo | Placebo Comparator | Clear liquid, single dose administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LG00034053 | Drug | a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC score from baseline to time point | Change of WOMAC (11-point NRS) score
| week 1 ~ week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emeritus Research | Camberwell | Australia | ||||
| The Catholic Univ. of Korea Seoul St. Mary's Hospital |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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) | week 1 ~ week 24 |
| Seoul |
| South Korea |
| D012216 |
| Rheumatic Diseases |