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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

NCT ID: NCT01464944

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Tract Infections Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 2

Group Type EXPERIMENTAL

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Type DRUG

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

Arm 3

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

Arm 4

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

Arm 5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Arm 1

Group Type EXPERIMENTAL

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Acetylsalicylic acid (Aspirin, BAYE4465)

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

Intervention Type DRUG

Paracetamol

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

Intervention Type DRUG

Paracetamol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Consumer Care, Inc.

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Kiev, , Ukraine

Site Status

Kiev, , Ukraine

Site Status

Luhansk, , Ukraine

Site Status

Countries

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Russia Ukraine

Other Identifiers

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11202

Identifier Type: -

Identifier Source: org_study_id