MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
111
MR-107A-02 oral tablet
Placebo oral tablet
Research Facility 201
Salt Lake City, Utah, United States
Overall Summed Pain Intensity Difference (SPID)
Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 18 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.
Time frame: 24 hours after the first dose
Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)
10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 6-hour windowed last observation carried forward (W6LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 6 hours when calculating SPIDs
Time frame: 24 hours after first dose
Time to Perceptible Pain Relief.
Measured by double stopwatch technique. The time to onset of first perceptible relief (time that the first watch is stopped) is defined as the postdose time at which the subject first begins to feel pain relief at their estimation.
Time frame: 24 hours after first dose
Time to Meaningful Pain Relief
Measured by double stopwatch technique The time to meaningful pain relief (time that the second watch is stopped) is defined as the postdose time at which the subject begins to feel meaningful pain relief at their estimation
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Time frame: 24 hours after first dose
Patient's Global Assessment of Pain Control
5 point PGA (Patient's Global Assessment) of pain control scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent Responder = 2 is good, 3 is very good, and 4 is excellent Non-responder = 1 is fair, 0 is poor, and missing values.
Time frame: 24 hours
Rescue Medication Use
Percentage of subjects using rescue medication from 0-24 hours
Time frame: 24 hours after first dose