This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects from the US will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
103
SCIREX Research Center
San Marcos, Texas, United States
SCIREX Research Center
Salt Lake City, Utah, United States
Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).
Time frame: 6 hours post dose 2
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Time frame: Duration of study
Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).
Time frame: Duration of study
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dose 2