A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
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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.
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 ]
Secondary Outcome Measures
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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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
Scheduled for outpatient oral surgical procedure to remove 2 ipsilateral third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
Body weight >50 kg (110 lbs).
Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
Additional criteria exist.
Key Exclusion Criteria:
Positive urine drug screen.
Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.