check_circleStudy Completed
Respiratory Tract Infections, Fever
Bayer Identifier:
11202
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Placebo and active controlled study to compare the antipyretic efficacy of Aspirin® in patients with acute febrile upper respiratory tract infections suspected to be of viral origin
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
392Trial Dates
November 2003 - April 2004Phase
Phase IVCould I Receive a placebo
YesProducts
Aspirin (Acetylsalicylic Acid, BAYE4465)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Moscow, 109386, Russia | |
Completed | Moscow, 127015, Russia | |
Completed | Moscow, 125183, Russia | |
Completed | Moscow, 105064, Russia | |
Completed | Moscow, 107996, Russia | |
Completed | Moscow, 127299, Russia | |
Completed | Kiev, 02232, Ukraine | |
Completed | Kiev, 02232, Ukraine | |
Completed | Kiev, 02232, Ukraine | |
Completed | Kiev, 03049, Ukraine | |
Completed | Kiev, 03049, Ukraine | |
Completed | Kiev, 03049, Ukraine | |
Completed | Lugansk, 91011, Ukraine | |
Completed | Lugansk, 91011, Ukraine |
Primary Outcome
- Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.date_rangeTime Frame:Up to 4 hours post doseenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Maximum temperature difference between baseline and the lowest measured temperaturedate_rangeTime Frame:Up to 4 hours post doseenhanced_encryptionnoSafety Issue:
- Time to reach the maximum temperature differencedate_rangeTime Frame:Up to 4 hours post doseenhanced_encryptionnoSafety Issue:
- Intensity of Upper Respiratory Tract Infection symptomsdate_rangeTime Frame:0, 2, 4, and 6 hours post doseenhanced_encryptionnoSafety Issue:
- Safety - assessment of adverse eventsdate_rangeTime Frame:Up to 7 hours post doseenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
5Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.Click here and search for drug information provided by the FDAClick here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this productClick here to find results for studies related to marketed products