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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02209181 | A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine | PHASE2 | COMPLETED | 269 | — | — | Aug 1, 2014 | Apr 1, 2015 | Feb 3, 2017 | 1 | United States |
Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).
| Arm | Type | Description |
|---|---|---|
| JNJ-10450232 250 mg | EXPERIMENTAL | - |
| JNJ-10450232 1000 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Acetaminophen 1000 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JNJ-10450232 / Not yet marketed | DRUG | Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. |
| acetaminophen / Tylenol | DRUG | Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. |
Inclusion Criteria: * Subjects aged 18-45 years * At least moderate dental pain assessed by a categorical scale pain intensity scale and a score of at least 5 on the 11-point (0-10) pain intensity numerical rating scale (PI-NRS) following surgical removal of three third-molars Exclusion Criteria: ...