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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Tract Infections
• Fever

Interventions

Type	Name	Description
DRUG	Acetylsalicylic acid (Aspirin, BAYE4465)	Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol
DRUG	Acetylsalicylic acid (Aspirin, BAYE4465)	Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol
DRUG	Paracetamol	Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid
DRUG	Paracetamol	Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
DRUG	Placebo	2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose

Timeline

• Start date: 2003-11-01
• Completion: 2004-04-01
• First posted: 2011-11-04
• Last updated: 2011-11-08

Locations

9 sites across 2 countries: Russia, Ukraine