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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01208207 | A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) | PHASE3 | COMPLETED | 1,015 | — | — | Sep 27, 2010 | Nov 12, 2014 | Jun 18, 2024 | - | — |
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated 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.
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated 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 60 mg/etoricoxib 60 mg | EXPERIMENTAL | The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg in Part I and Part II |
| etoricoxib 60 mg/etoricoxib 90 mg | EXPERIMENTAL | The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg in Part I and etoricoxib 90 mg in Part II |
| etoricoxib 90 mg/etoricoxib 90 mg | EXPERIMENTAL | The etoricoxib 90 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg in Part I and Part II |
| naproxen 1000 mg/naproxen 1000 mg | ACTIVE_COMPARATOR | The naproxen 1000 mg/naproxen 1000 mg treatment sequence will receive naproxen 1000 mg in Part I and Part II |
| Name | Type | Description |
|---|---|---|
| Part I - etoricoxib 60 mg | DRUG | etoricoxib 60 mg oral tablet once daily for 6 weeks |
| Part I - etoricoxib 90 mg | DRUG | etoricoxib 90 mg oral tablet once daily for 6 weeks |
| Part I- naproxen 1000 mg | DRUG | naproxen 500 mg oral tablet twice daily for 6 weeks |
| Part I - Placebo to naproxen 500 mg | DRUG | Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks |
| Part II- etoricoxib 60 mg | DRUG | etoricoxib 60 mg oral tablet once daily for 20 weeks |
| Part II- etoricoxib 90 mg | DRUG | etoricoxib 90 mg oral tablet once daily for 20 weeks |
| Part II- naproxen 1000 mg | DRUG | naproxen 500 mg oral tablet twice daily for 20 weeks |
| Part I - Placebo to etoricoxib 60 mg | DRUG | Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks. |
| Part I - Placebo to etoricoxib 90 mg | DRUG | Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks. |
| Part II- Placebo to etoricoxib 60 mg | DRUG | Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks. |
| Part II - Placebo to etoricoxib 90 mg | DRUG | Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks. |
| Part II- Placebo to naproxen 500 mg | DRUG | Placebo to naproxen 500 mg orally twice daily for 20 weeks. |
Inclusion Criteria: * Has a definite diagnosis of Ankylosing Spondylitis (AS) per Modified New York Criteria made at least 6 months prior to screening * Has a history of positive therapeutic benefit with non-steroidal anti-inflammatory drugs (NSAIDs) and regular use of NSAIDS for past 30 days * Has...