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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01107236 | Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction | PHASE2 | COMPLETED | 90 | — | — | Jun 1, 2010 | Aug 1, 2010 | Aug 11, 2022 | 1 | United States |
Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
| Arm | Type | Description |
|---|---|---|
| IW-6118 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Naproxen Sodium | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| IW-6118 | DRUG | Single dose |
| Matching Placebo | DRUG | Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium |
| Naproxen Sodium | DRUG | Single dose |
Inclusion Criteria: * Between 18 and 30 years old at time of screening; * BMI \> 18.5 and \< 30.0; * In overall good health with no clinically-significant laboratory, ECG, or physical exam findings; * Patient requires two ipsilateral third molar extractions of which one must be a full or partial bo...