check_circleStudy Completed

Respiratory Tract Infections, Fever

Bayer Identifier:

11202

ClinicalTrials.gov Identifier:

NCT01464944

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - 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
  • - 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
November 2003 - April 2004
Phase
Phase IV
Could I Receive a placebo
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Moscow, 109386, Russia
Completed
Moscow, 127015, Russia
Completed
Moscow, 125183, Russia
Completed
Moscow, 105064, Russia
Completed
Moscow, 107996, Russia
Completed
Moscow, 127299, Russia
Completed
Kiev, 02232, Ukraine
Completed
Kiev, 02232, Ukraine
Completed
Kiev, 02232, Ukraine
Completed
Kiev, 03049, Ukraine
Completed
Kiev, 03049, Ukraine
Completed
Kiev, 03049, Ukraine
Completed
Lugansk, 91011, Ukraine
Completed
Lugansk, 91011, Ukraine

Primary Outcome

  • Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.
    date_rangeTime Frame:
    Up to 4 hours post dose
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Maximum temperature difference between baseline and the lowest measured temperature
    date_rangeTime Frame:
    Up to 4 hours post dose
    enhanced_encryption
    Safety Issue:
    no
  • Time to reach the maximum temperature difference
    date_rangeTime Frame:
    Up to 4 hours post dose
    enhanced_encryption
    Safety Issue:
    no
  • Intensity of Upper Respiratory Tract Infection symptoms
    date_rangeTime Frame:
    0, 2, 4, and 6 hours post dose
    enhanced_encryption
    Safety Issue:
    no
  • Safety - assessment of adverse events
    date_rangeTime Frame:
    Up to 7 hours post dose
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
5

Additional Information

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