Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
NCT ID: NCT01062360
Last Updated: 2017-09-01
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
PHASE3
1016 participants
INTERVENTIONAL
2005-12-23
2007-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine
Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Arm 2
Acetylsalicylic Acid (Aspirin, BAYE4465)
Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Arm 3
Pseudoephedrine
Single oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Arm 4
Placebo
Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Interventions
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Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine
Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Acetylsalicylic Acid (Aspirin, BAYE4465)
Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Pseudoephedrine
Single oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Placebo
Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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New York, New York, United States
New York, New York, United States
Alassio, , Italy
Albenga, , Italy
Arenzano, , Italy
Civitella Marittima, , Italy
Follonica, , Italy
Genova, , Italy
Genova, , Italy
Genova, , Italy
Genova, , Italy
Genova, , Italy
Genova, , Italy
Genova, , Italy
Genova, , Italy
Genova, , Italy
Genova, , Italy
Grosseto, , Italy
Grossetto, , Italy
Isola del Cantone, , Italy
Loano, , Italy
Masone, , Italy
Orbetello, , Italy
Pegli, , Italy
Quiliano, , Italy
Rivarolo, , Italy
Ronco Scrivia, , Italy
Sampierdarena, , Italy
Scansano, , Italy
Serra Riccò, , Italy
Varazze, , Italy
Ciechocin, , Poland
Dębowa Góra, , Poland
Katowice, , Poland
Katowice, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Piaseczno, , Poland
Skierniewice, , Poland
Szczecin, , Poland
Szczecin, , Poland
Torun, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Zabrze, , Poland
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Pezinok, , Slovakia
Stupava, , Slovakia
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2005-001720-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11764
Identifier Type: -
Identifier Source: org_study_id
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