The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg (2 x 325 mg) and placebo in subjects with postsurgical dental pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
Single dose of fast acting aspirin 2 x 325 mg = 650 mg total
Single dose of regular aspirin 2 x 325 mg = 650 mg total
Two placebo tablets
Unnamed facility
Austin, Texas, United States
Unnamed facility
Salt Lake City, Utah, United States
Time to First Perceptible Pain Relief (PR)
Time frame: 0 to 6 hours
Time to First Perceptible Pain Relief Confirmed
Time frame: 0 to 6 hours
Time to meaningful pain relief
Time frame: 0 to 6 hours
Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
Time frame: 10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours post-dose
Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
Time frame: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
Time frame: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6
Time frame: 0 - 6 hours post-dose
Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6
Time frame: 0-6 hours post-dose
Time to First use of Rescue Medication
Time frame: 0 to 6 hours
Cumulative Percentage of Subjects Taking Rescue Medication
Time frame: 1, 2, 3, 4, 5, and 6 hours post-dose
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Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication
Time frame: At 6 hours postdose or immediately before first use of rescue medication