Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Respiratory Tract Infections
Fever
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 efficac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT01464944
Start Date
November 1 2003
End Date
April 1 2004
Last Update
November 8 2011
Active Locations (9)
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1
Moscow, Russia, 105064
2
Moscow, Russia, 107996
3
Moscow, Russia, 109386
4
Moscow, Russia, 125183