The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000 mg (2 x 500 mg) and placebo in subjects with postsurgical dental pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
514
Single oral dose of fast release aspirin tablets 1000 mg (2 x 500 mg) with a full glass of water (240 milliliter \[mL\]) between 14 hours post dental surgery.
Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 14 hours post dental surgery.
Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 14 hours post dental surgery.
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 (PR) Confirmed
Time frame: 0 to 6 hours
Time to Meaningful Pain Relief (PR)
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
Pain Intensity (PI) was rated by subjects on a 4-point Categorical Pain Intensity Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose.
Time frame: 10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours postdose
Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing
Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose. For each post-dose time point, PID was derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement.
Time frame: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose
Pain Relief at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing
Pain relief was rated by subjects using a 5-point Categorical Relief Rating Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
Time frame: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose
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Summed Pain Intensity Differences (SPID) From Hour 0 Through Hour 2, Hour 4 and Hour 6
Time frame: 0 to 6 hours postdose
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 postdose
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