The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
203
Capsules 2 x 200 mg Single-Dose
Capsules 2 Single-Dose
20-mg single dose
Premier Research Group Limited
Austin, Texas, United States
Total Patient Pain Relief Over 0 to 8 Hours.
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32.
Time frame: 8 hours
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40-mg single dose