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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02320708 | Study of Acetaminophen (ACE) in Post-operative Dental Pain | PHASE2 | COMPLETED | 240 | — | — | Dec 31, 2014 | Apr 30, 2015 | Dec 3, 2021 | 1 | United States |
Time weighted sum of pain intensity difference scores from baseline over 6 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
| Arm | Type | Description |
|---|---|---|
| Test Acetaminophen (ACE) (1000 mg) and placebo | EXPERIMENTAL | - |
| Commerical ACE (1000 mg) and placebo | ACTIVE_COMPARATOR | - |
| Commerical Ibuprofen (IBU) (400 mg) and placebo | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Acetaminophen (ACE) (1000 mg) | DRUG | 2 Test ACE 500 mg tablets taken orally one time |
| Commercial ACE (1000 mg) | DRUG | 2 ACE 500 mg caplets taken orally one time |
| Commercial Ibuprofen (IBU) (400 mg) | DRUG | 2 IBU 200 mg soft-gels taken orally one time |
| Placebo | DRUG | 2 placebo caplets for acetaminophen taken orally one time |
Inclusion Criteria: 1. Are 17 to 50 years of age 2. Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive) 3. Dental extraction of three or four third-molars. 4. Experience moderate to severe pain after extraction of third molars Exclusion Criteria: 1. Currently pregnant (or plan...