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

Fever Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464944
• Other study ID #: 11202
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2011
• Last updated: November 7, 2011
• Start date: November 2003
• Est. completion date: April 2004

Study information

• Verified date: November 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Fever
• Infection
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.		Up to 4 hours post dose	No
Secondary	Maximum temperature difference between baseline and the lowest measured temperature		Up to 4 hours post dose	No
Secondary	Time to reach the maximum temperature difference		Up to 4 hours post dose	No
Secondary	Intensity of Upper Respiratory Tract Infection symptoms		0, 2, 4, and 6 hours post dose	No
Secondary	Safety - assessment of adverse events		Up to 7 hours post dose	Yes

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