Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01554163 | Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis | PHASE3 | COMPLETED | 239 | — | — | Mar 1, 2012 | Mar 1, 2013 | Feb 9, 2022 | - | — |
The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
| Arm | Type | Description |
|---|---|---|
| Etoricoxib 30 mg | EXPERIMENTAL | Etoricoxib, 30 mg tablet, orally, once daily for 12 weeks. |
| Celecoxib 200 mg | ACTIVE_COMPARATOR | Celecoxib, 200 mg capsule, orally, once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Etoricoxib 30 mg | DRUG | Etoricoxib 30 mg tablet once daily for 12 weeks. |
| Celecoxib 200 mg | DRUG | Celecoxib 200 mg once daily for 12 weeks |
Inclusion Criteria: * Patient is at least 40 years of age * Clinical diagnosis of osteoarthritis of the knee for greater than 6 months based on clinical and radiographic criteria * Female patients of childbearing potential must have a negative pregnancy test prior to study enrollment and must agree...