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:

NCT01464944

EudraCT Number:

Not Available

Study Completed

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
392
Trial Dates
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Phase
IV
Could I receive a placebo?
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Moscow, Russia, 109386

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 127015

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 125183

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 105064

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 107996

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 127299

Status
Completed
 
Locations

Investigative Site

Kiev, Ukraine, 02232

Status
Completed
 
Locations

Investigative Site

Kiev, Ukraine, 03049

Status
Completed
 
Locations

Investigative Site

Lugansk, Ukraine, 91011

Status
Completed
 

Trial Design