The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.
This is a randomized, double-blind, placebo-controlled, single-dose full-factorial study to evaluate the analgesic efficacy and safety of a fixed combination of acetaminophen and naproxen sodium, compared with acetaminophen or naproxen sodium alone, and placebo following surgical extraction of three or four third molars.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
447
Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
Naproxen Sodium will be administered orally.
Acetaminophen will be administered orally.
JBR Clinical Research LLC
Salt Lake City, Utah, United States
Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12)
Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.
Time frame: 0 to 12 hours
Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)
Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.
Time frame: 6 to 12 hours
Time to First Request of Rescue Analgesic
Time to first request for rescue medication will be measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.
Time frame: 0 to 24 hours
Percentage of Participants who Request Rescue Analgesic During the First 12 hours
Percentage of participants who request rescue analgesic during the first 12 hours will be reported.
Time frame: 0 to 12 hours
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Placebo will be administered orally.