drugset / Trial / NCT01464944

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

NCT01464944 ↗

Phase 4 Completed 392 enrolled Bayer
RandomizedParallel-groupTriple-blindTreatment

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 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.

Timeline

Start
2003-11
Primary completion
—
Completion
2004-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 500 mg Oral
Comparator Acetaminophen Small molecule 1000 mg Oral
Subject Aspirin Small molecule 500 mg Oral
Subject Aspirin Small molecule 1000 mg Oral