This study is addressed to patients suffering from an acute febrile upper respiratory tract infection suspected to be of viral origin. The purpose of this study is to determine the antipyretic efficacy (reduction of fever by lowering the body temperature from a raised state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo (comparator medication without an active substance). Despite of its common use for fever treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin are sparse. Therefore, the purpose of this study is to collect such data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
392
Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol
Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid
Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Kiev, Ukraine
Unnamed facility
Kiev, Ukraine
Unnamed facility
Luhansk, Ukraine
Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.
Time frame: Up to 4 hours post dose
Maximum temperature difference between baseline and the lowest measured temperature
Time frame: Up to 4 hours post dose
Time to reach the maximum temperature difference
Time frame: Up to 4 hours post dose
Intensity of Upper Respiratory Tract Infection symptoms
Time frame: 0, 2, 4, and 6 hours post dose
Safety - assessment of adverse events
Time frame: Up to 7 hours post dose
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