The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Subjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm.
Jean Brown Research
Salt Lake City, Utah, United States
SPID (Sum Pain Intensity Difference)
The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)
Time frame: 0-48 hours
spontaneous muscle pain/soreness
Time frame: 0-48 hours
Muscle stiffness with movement
Time frame: 0-48 hours
Overall evaluation measures
Time frame: 0-48 hours
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