Study Results
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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COMPLETED
PHASE4
388 participants
INTERVENTIONAL
2005-10-31
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 2
Placebo
1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
Arm 1
Aspirin (Acetylsalicylic acid, BAYE4465)
1-2 tablets Acetylsalicylic Acid 400 mg (in combination with Ascorbic Acid 240 mg) as needed every 4-6 hours over a maximum of 5 days
Interventions
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Aspirin (Acetylsalicylic acid, BAYE4465)
1-2 tablets Acetylsalicylic Acid 400 mg (in combination with Ascorbic Acid 240 mg) as needed every 4-6 hours over a maximum of 5 days
Placebo
1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
Eligibility Criteria
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Inclusion Criteria
* Onset of cold symptoms within 48 hours before screening
* Objective symptoms of common cold
* Subjective symptoms of common cold
Exclusion Criteria
* Active peptic ulcer
* Hemorrhagic diathesis
* History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding
* Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens
18 Years
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
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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Borgo di Terzo, Bergamo, Italy
Brembate, Bergamo, Italy
Calusco d'Adda, Bergamo, Italy
Capriate San Gervasio, Bergamo, Italy
Caravaggio, Bergamo, Italy
Casazza, Bergamo, Italy
Cologno al Serio, Bergamo, Italy
Covo, Bergamo, Italy
Dalmine, Bergamo, Italy
Mozzanica, Bergamo, Italy
Ponte San Pietro, Bergamo, Italy
Seriate, Bergamo, Italy
Verdello, Bergamo, Italy
Vertova, Bergamo, Italy
Villa d'Adda, Bergamo, Italy
Angera, Varese, Italy
Carnago, Varese, Italy
Cavaria, Varese, Italy
Comerio, Varese, Italy
Cunardo, Varese, Italy
Fagnano Olona, Varese, Italy
Induno Olona, Varese, Italy
Sesto Calende, Varese, Italy
Solbiate Olona, Varese, Italy
Varese, Varese, Italy
Vedano Olona, Varese, Italy
Vergiate, Varese, Italy
Albano Sant'Alessandro, , Italy
Countries
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Other Identifiers
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EudraCT: 2004-004683-71
Identifier Type: -
Identifier Source: secondary_id
11756
Identifier Type: -
Identifier Source: org_study_id