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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00694369 | A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092) | PHASE3 | COMPLETED | 588 | — | — | Jun 1, 2008 | Jan 1, 2009 | Feb 9, 2022 | - | — |
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | etoricoxib 90 mg |
| 2 | EXPERIMENTAL | etoricoxib 120 mg |
| 3 | ACTIVE_COMPARATOR | ibuprofen 2400 mg |
| 4 | ACTIVE_COMPARATOR | acetaminophen 2400 mg/codeine 240 mg |
| 5 | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| Comparator: etoricoxib | DRUG | etoricoxib 90 mg; 120 mg (once daily) over three days. |
| Comparator: ibuprofen | DRUG | ibuprofen 2400 mg (600 mg Q6h) over three Days |
| Comparator: acetaminophen + codeine | DRUG | acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days |
| Comparator: placebo | DRUG | matching placebo over three Days |
Inclusion Criteria: * Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw * Patients must be experiencing moderate to severe pain following the dental procedure Exclusion Criteria: * Previous molar e...