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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01529346 | Efficacy Of PF-05089771 In Treating Postoperative Dental Pain | PHASE2 | COMPLETED | 235 | — | — | Dec 12, 2011 | Jun 25, 2012 | Jun 1, 2018 | 3 | United States |
TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework.
| Arm | Type | Description |
|---|---|---|
| PF-05089771 1600 mg | EXPERIMENTAL | - |
| PF-05089771 450 mg | EXPERIMENTAL | - |
| PF-05089771 150 mg | EXPERIMENTAL | - |
| Ibuprofen 400 mg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-05089771 | DRUG | A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively |
| Placebo | OTHER | Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively |
| Ibuprofen | DRUG | 2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively |
Inclusion Criteria: * Oral surgery having removed 2 unilateral third molar teeth. * Pre-dose pain intensity score (100 mm VAS \[VAS\]) of at least 50mm within 5 hours of oral surgery * Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery Exclusion Criteria: * Presenc...