The primary objective of this study is to assess the analgesic properties of an oral dose of V117957 4.5 mg aqueous suspension in the third molar extraction model
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
114
PPD Dental Pain Clinic
Austin, Texas, United States
Total pain relief 0 to 8 hours after dosing (TOTPAR8)
Time-weighted sum of pain relief scores 0 to 8 hours after dosing
Time frame: 0 - 8 hours postdose
Total Pain Relief 0 - 4 hours after dosing (TOTPAR4)
Time frame: Hour 4 postdose
Total Pain Relief 0 - 6 hours after dosing (TOTPAR6)
Time frame: Hour 6 postdose
Total Pain Relief 0 - 12 hours after dosing (TOTPAR12)
Time frame: Hour 12 postdose
Total Pain Relief 0 - 24 hours after dosing (TOTPAR24)
Time frame: Hour 24 postdose
Pain Relief (PR) over time
Time frame: Up to 24 hours postdose
Pain intensity difference over time
Time frame: 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)
Time frame: Hour 4 postdose
Sum of pain intensity difference 0 to 6 hours after dosing (SPID6)
Time frame: Hour 6 postdose
Sum of pain intensity difference 0 to 8 hours after dosing (SPID8)
Time frame: Hour 8 postdose
Sum of pain intensity difference 0 to 12 hours after dosing (SPID12)
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Time frame: Hour 12 postdose
Sum of pain intensity difference 0 to 24 hours after dosing (SPID24)
Time frame: Hour 24 postdose
Time to first perceptible PR
Time frame: Up to 24 hours postdose
Time to meaningful PR
Time frame: Up to 24 hours postdose
Time to first use of rescue pain medication
Time frame: Up to 24 hours postdose
Proportion of subjects taking rescue medication by time point
Time frame: Up to 24 hours postdose
Global assessment of overall satisfaction
Time frame: Hour 24 postdose