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The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH23537 | Experimental | YH23537 750/1500/3000mg |
|
| Celebrex | Active Comparator | Celecoxib 200mg |
|
| Placebo | Placebo Comparator | YH23537 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH23537 | Drug | Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in VAS score to assess pain at Week 12 | baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in VAS score to assess pain at Week 4, 8 | baseline, week 4 and week 8 | |
| Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12 | baseline, week 4, week 8 and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life measured by SF-12 at Week 12 | week 12 | |
| Percentage of patients who had taken rescue medication at week 12 | week 12 | |
| Amount of rescue medication tablets taken following the investigational product |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon Je Cho, M.D, Ph.D | Kyunghee University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KyungHee University Medical Center | Seoul | 02447 | South Korea |
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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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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Celecoxib | Drug | Drug: Celecoxib 200mg |
|
|
| YH23537 placebo | Drug | Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo |
|
| Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12 | baseline, week 4, week 8 and week 12 |
| Percentage From Baseline in WOMAC responder at Week 4, 8, 12 | baseline, week 4, week 8 and week 12 |
| Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12 | week 12 |
| Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12 | week 12 |
| week 12 |
| The number of days taken rescue medication following the investigational product | week 12 |
| Change From Baseline in Kellgren-Lawrence(KL) grading scale to assess the severity of knee osteoarthritis on a plain radiograph at Week 12 | week 12 |
| Change From Baseline in International knee documentation committee(IKDC) score at Week 4, 8, 12 | week 4, 8, 12 |
| D012216 |
| Rheumatic Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |