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NCT Number: 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

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.

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Key information

Conditions

Respiratory Tract Infections Body Temperature Changes Fever Infections Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol

Paracetamol

Drug

Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid

Placebo

Drug

2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose

Primary outcomes

  1. Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.

    Time frame: Up to 4 hours post dose

Secondary outcomes

  1. Maximum temperature difference between baseline and the lowest measured temperature

    Time frame: Up to 4 hours post dose

  2. Time to reach the maximum temperature difference

    Time frame: Up to 4 hours post dose

  3. Intensity of Upper Respiratory Tract Infection symptoms

    Time frame: 0, 2, 4, and 6 hours post dose

  4. Safety - assessment of adverse events

    Time frame: Up to 7 hours post dose

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Study completion
2004
First posted
Nov 4, 2011
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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