This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
PPD Phase I Clinic
Austin, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).
Time frame: 6 hours post-dose
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
Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication].
Time frame: Duration of study
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dose 1: multiple dose levels; dose 2
dose 1
dose 2
dose 2