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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001720-36 | EudraCT Number |
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The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Active Comparator |
| |
| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing | 2 hours | |
| The primary efficacy parameter for sore throat was SPID2 hours | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose | 15, 30, 60, 90, 120, 240, and 360 minutes | |
| The Nasal Congestion Score | 15, 30, 60, 90, 120, 240, and 360 minutes |
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Inclusion Criteria:- Male and female subjects between 18 and 65 years of age.- Onset of cold symptoms within 96 hours (4 days) before study participation.- Current complaint of at least moderate sore throat at baseline- Current complaint of at least moderate NC at baseline- History of other symptoms associated with URTI during the last 4 days before study participation.- Other findings of URTI, confirmed on the physical examination.- Agreement to comply with the study requirements.- Written informed consent prior to enrollment in the study Exclusion Criteria:- Pregnant or lactating females.- Uncontrolled chronic diseases.- History of hypersensitivity (allergic reaction) to ASA, any other nonsteroidal anti-inflammatory drugs (NSAIDs), or PSE.- Any disease which significantly compromises breathing or interferes with the subjects assessment of sore throat.- History of or active peptic ulcer.- Severe impaired hepatic function.- Severe impaired renal function.- Simultaneous intake of monoamine oxidase inhibitors.- Use of menthol containing tissues within 2 hours before first intake of study drug.- Intake of any menthol containing product within 4 hours before first intake of study drug.- Use of any local or systemic short acting cough and cold preparations within 6 hours before first intake of study drug.- Use of any local or systemic long acting cough and cold preparations within 12 hours before first intake of study drug.- Intake of any analgesic within 12 hours before first intake of study drug.- Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection.- Current or previous intake of anticoagulants, corticoids, NSAIDs, methotrexate, or lithium.- Participation in another clinical trial within the last 30 days.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York | New York | 11021 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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|
| Acetylsalicylic Acid (Aspirin, BAYE4465) | Drug | 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 | Drug | 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 | Drug | 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. |
|
| The Nasal Congestion Relief Score | 15, 30, 60, 90, 120, 240, and 360 minutes |
| Sore throat pain relief | 15, 30, 60, 90, 120, 240, and 360 minutes |
| The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose | 120 minutes |
| The results of an overall assessment of treatment by the subjects at 120 minutes post dose | 120 minutes |
| The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug) | Day 3 |
| Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake) | Day 3 |
| The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake) | Day 2 and Day 3 |
| Total amount of drug intake | Day 3 |
| New York |
| New York |
| 11743 |
| United States |
| Alassio | 17021 | Italy |
| Albenga | 17031 | Italy |
| Arenzano | 16011 | Italy |
| Civitella Marittima | 58048 | Italy |
| Follonica | 58022 | Italy |
| Genova | 16010 | Italy |
| Genova | 16125 | Italy |
| Genova | 16128 | Italy |
| Genova | 16129 | Italy |
| Genova | 16131 | Italy |
| Genova | 16137 | Italy |
| Genova | 16143 | Italy |
| Genova | 16149 | Italy |
| Genova | 16161 | Italy |
| Genova | 16162 | Italy |
| Grosseto | 58100 | Italy |
| Grossetto | 58100 | Italy |
| Isola del Cantone | 16017 | Italy |
| Loano | 17025 | Italy |
| Masone | 16010 | Italy |
| Orbetello | 58100 | Italy |
| Pegli | 16100 | Italy |
| Quiliano | 17047 | Italy |
| Rivarolo | 16150 | Italy |
| Ronco Scrivia | 16019 | Italy |
| Sampierdarena | 16151 | Italy |
| Scansano | 58054 | Italy |
| Serra Riccò | 16010 | Italy |
| Varazze | 17019 | Italy |
| Ciechocin | 87-408 | Poland |
| Dębowa Góra | 96-116 | Poland |
| Katowice | 40-226 | Poland |
| Katowice | 40-520 | Poland |
| Katowice | 40-752 | Poland |
| Krakow | 31-215 | Poland |
| Lodz | 93-105 | Poland |
| Piaseczno | 05-500 | Poland |
| Skierniewice | 96-100 | Poland |
| Szczecin | 71-140 | Poland |
| Szczecin | 71-502 | Poland |
| Torun | 87-100 | Poland |
| Warsaw | 01-493 | Poland |
| Warsaw | 01-961 | Poland |
| Warsaw | 02-091 | Poland |
| Warsaw | 02-097 | Poland |
| Warsaw | 02-793 | Poland |
| Warsaw | 03-185 | Poland |
| Zabrze | 41-800 | Poland |
| Bratislava | 81107 | Slovakia |
| Bratislava | 84101 | Slovakia |
| Bratislava | 84104 | Slovakia |
| Bratislava | 84107 | Slovakia |
| Bratislava | 85101 | Slovakia |
| Bratislava | 85102 | Slovakia |
| Bratislava | 85105 | Slovakia |
| Pezinok | 90201 | Slovakia |
| Stupava | 90031 | Slovakia |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009668 | Nose Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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