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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
| |
| Arm 4 | Active Comparator |
| |
| Arm 5 | Placebo Comparator |
| |
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid (Aspirin, BAYE4465) | Drug | Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose. | Up to 4 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum temperature difference between baseline and the lowest measured temperature | Up to 4 hours post dose | |
| Time to reach the maximum temperature difference | Up to 4 hours post dose | |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow | 105064 | Russia | ||||
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| Acetylsalicylic acid (Aspirin, BAYE4465) | Drug | Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol |
|
| Paracetamol | Drug | Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid |
|
| Paracetamol | Drug | Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid |
|
| Placebo | Drug | 2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose |
|
| Intensity of Upper Respiratory Tract Infection symptoms |
| 0, 2, 4, and 6 hours post dose |
| Safety - assessment of adverse events | Up to 7 hours post dose |
| Moscow |
| 107996 |
| Russia |
| Moscow | 109386 | Russia |
| Moscow | 125183 | Russia |
| Moscow | 127015 | Russia |
| Moscow | 127299 | Russia |
| Kiev | 02232 | Ukraine |
| Kiev | 03049 | Ukraine |
| Luhansk | 91011 | Ukraine |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D005334 | Fever |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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