This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Pfizer Investigational Site
Cypress, California, United States
Pfizer Investigational Site
Westlake Village, California, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
Time frame: 0 to 6 hours
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)
STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
Time frame: 0 to 4, 0 to 8 hours
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8
Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
Time frame: Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours
Time to Treatment Failure
Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.
Time frame: 0 to 8 hours
Cumulative Percentage of Participants With Treatment Failure
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Time frame: 0.25, 0.5, 1, 2, 4, 6, 8 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pfizer Investigational Site
Salt Lake City, Utah, United States
Global Assessment of Study Medication as an Antipyretic
Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
Time frame: 8 hours
Rating of Study Medication Relative to Usual Medication
Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
Time frame: 8 hours