A Phase 2a, Single-Center, Randomized, Double-Blind, Double- Dummy, Placebo- and Active-Controlled Analgesic Study of an Oral Dose of V117957 4.5 mg for the Treatment of Postsurgical Pain Due to Third Molar Extraction

简要总结

主要结局

次要结局

• Time to meaningful PR(Up to 24 hours postdose)
• Time to first use of rescue pain medication(Up to 24 hours postdose)
• Proportion of subjects taking rescue medication by time point(Up to 24 hours postdose)
• Global assessment of overall satisfaction(Hour 24 postdose)
• Total Pain Relief 0 - 4 hours after dosing (TOTPAR4)(Hour 4 postdose)
• Total Pain Relief 0 - 6 hours after dosing (TOTPAR6)(Hour 6 postdose)
• Total Pain Relief 0 - 12 hours after dosing (TOTPAR12)(Hour 12 postdose)
• Total Pain Relief 0 - 24 hours after dosing (TOTPAR24)(Hour 24 postdose)
• Pain Relief (PR) over time(Up to 24 hours postdose)
• Pain intensity difference over time(15, 30, 45 , 60, 90 minutes; 2, 3, 4, 4.5, 6, 8, 10, 12 and 24 hours postdose)
• Sum of pain intensity difference 0 to 4 hours after dosing (SPID4)(Hour 4 postdose)
• Sum of pain intensity difference 0 to 6 hours after dosing (SPID6)(Hour 6 postdose)
• Sum of pain intensity difference 0 to 8 hours after dosing (SPID8)(Hour 8 postdose)
• Sum of pain intensity difference 0 to 12 hours after dosing (SPID12)(Hour 12 postdose)
• Sum of pain intensity difference 0 to 24 hours after dosing (SPID24)(Hour 24 postdose)
• Time to first perceptible PR(Up to 24 hours postdose)