Trial Condition(s):
Respiratory Tract Infections, Fever
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
Bayer Identifier:
11202
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Ambulatory male or female patients 18 to 65 years of age - Acute uncomplicated febrile URTI suspected to be of viral origin and present not more than 5 days - Symptoms of a viral URTI - Oral temperature >/= 38.5 °C to </= 40°C
Exclusion Criteria
- Patients with physical findings consistent with the diagnosis of pneumonia, otitis media, bacterial sinusitis or any other bacterial infection of the respiratory tract requiring antibiotics or other therapeutic intervention by a physician - Current antibiotic treatment or pre-treatment with antibiotic agents during the last week - History or presence of asthma or hypersensitivity to ASA, salicylates, paracetamol, or other non-steroidal anti-inflammatory drugs; peptic ulceration or gastric bleeding; hemorrhagic diathesis; hepatic and/or renal dysfunction; Gilbert's disease; Quincke's edema - Any other acute or chronic disease which in the opinion f the investigator could interfere with the patient's health and well-being during the conduct of the study or which could interfere with the evaluation of data generated from this subject - Any conditions possibly interfering with the gastro-intestinal absorption of the study medication - Pregnant or lactating women. All women of childbearing age were to undergo a pregnancy test before start of the study
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Moscow, Russia, 109386 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 127015 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 125183 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 105064 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 107996 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 127299 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 02232 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 03049 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lugansk, Ukraine, 91011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blind, double-dummy, single-dose, parallel group, multicenter study to compare the antipyretic efficacy of acetylsalicy-lic acid 500 mg and 1,000 mg (2 x 500 mg) and paracetamol 500 mg and 1,000 mg (2 x 500 mg) with placebo in patients with acute febrile upper respiratory tract infections suspected to be of viral origin.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
5
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.Timeframe: Up to 4 hours post dose
Secondary Outcome
- Maximum temperature difference between baseline and the lowest measured temperatureTimeframe: Up to 4 hours post dose
- Time to reach the maximum temperature differenceTimeframe: Up to 4 hours post dose
- Intensity of Upper Respiratory Tract Infection symptomsTimeframe: 0, 2, 4, and 6 hours post dose
- Safety - assessment of adverse eventsTimeframe: Up to 7 hours post dose
Additional Information
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