To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
312
Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery
Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery
Unnamed facility
Austin, Texas, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
Salt Lake City, Utah, United States
Summed Pain Intensity Difference (SPID)
Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.
Time frame: 0 to 24 hours post dose
Total Pain Relief (TOTPAR)
Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
Time frame: 0-24 hours post dose
Summed Pain Intensity Difference at Specific Time Intervals
Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.
Time frame: 0-16 hours post dose
Time to First Use of Rescue Medication
Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.
Time frame: postdose to first use of rescue medication
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Global Assessment of the Investigational Product as a Pain Reliever
Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).
Time frame: at 24 hours postdose or immediately before first use of rescue medication
Time to Onset of Effect
Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both "perceptible" and "meaningful" pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them.
Time frame: from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours