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 has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01464944
First received: May 17, 2011
Last updated: November 7, 2011
Last verified: November 2011
  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.


Condition Intervention Phase
Respiratory Tract Infections
Fever
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Drug: Paracetamol
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum temperature difference between baseline and the lowest measured temperature [ Time Frame: Up to 4 hours post dose ] [ Designated as safety issue: No ]
  • Time to reach the maximum temperature difference [ Time Frame: Up to 4 hours post dose ] [ Designated as safety issue: No ]
  • Intensity of Upper Respiratory Tract Infection symptoms [ Time Frame: 0, 2, 4, and 6 hours post dose ] [ Designated as safety issue: No ]
  • Safety - assessment of adverse events [ Time Frame: Up to 7 hours post dose ] [ Designated as safety issue: Yes ]

Enrollment: 392
Study Start Date: November 2003
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: Arm 2 Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol
Active Comparator: Arm 3 Drug: Paracetamol
Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid
Active Comparator: Arm 4 Drug: Paracetamol
Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
Placebo Comparator: Arm 5 Drug: Placebo
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose
Experimental: Arm 1 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464944

Locations
Russian Federation
Moscow, Russian Federation, 109386
Moscow, Russian Federation, 127015
Moscow, Russian Federation, 125183
Moscow, Russian Federation, 105064
Moscow, Russian Federation, 107996
Moscow, Russian Federation, 127299
Ukraine
Kiev, Ukraine, 02232
Kiev, Ukraine, 03049
Lugansk, Ukraine, 91011
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Consumer Care, Inc.
ClinicalTrials.gov Identifier: NCT01464944     History of Changes
Other Study ID Numbers: 11202
Study First Received: May 17, 2011
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Upper Respiratory Tract Infections

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Acetaminophen
Aspirin
Antipyretics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014