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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2004-004683-71 |
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A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Placebo Comparator |
| |
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin (Acetylsalicylic acid, BAYE4465) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline | 2 hours following intake of the first study medication dose |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Common Cold Profile (sum of WURSS domains 1 182 3) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) | |
| Changes in Global Cold Severity (WURSS domain 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Borgo di Terzo | Bergamo | 24060 | Italy | |||
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | 1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days |
|
| At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
| Changes in Cold Symptoms (WURSS domain 2) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
| Changes in Cold-specific Functional Impairments (WURSS domain 3) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
| Changes in Global Cold Severity (WURSS domain 4) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
| Adverse Event Collection | Until end of study |
| Brembate |
| Bergamo |
| 24041 |
| Italy |
| Calusco d'Adda | Bergamo | 24033 | Italy |
| Capriate San Gervasio | Bergamo | 24042 | Italy |
| Caravaggio | Bergamo | 24043 | Italy |
| Casazza | Bergamo | 24060 | Italy |
| Cologno al Serio | Bergamo | 24055 | Italy |
| Covo | Bergamo | 24050 | Italy |
| Dalmine | Bergamo | 24044 | Italy |
| Mozzanica | Bergamo | 24050 | Italy |
| Ponte San Pietro | Bergamo | 24036 | Italy |
| Seriate | Bergamo | 24068 | Italy |
| Verdello | Bergamo | 24049 | Italy |
| Vertova | Bergamo | 24029 | Italy |
| Villa d'Adda | Bergamo | 24030 | Italy |
| Angera | Varese | 21021 | Italy |
| Carnago | Varese | 21040 | Italy |
| Cavaria | Varese | 21044 | Italy |
| Comerio | Varese | 21025 | Italy |
| Cunardo | Varese | 21035 | Italy |
| Fagnano Olona | Varese | 21054 | Italy |
| Induno Olona | Varese | 21056 | Italy |
| Sesto Calende | Varese | 21018 | Italy |
| Solbiate Olona | Varese | 21058 | Italy |
| Varese | Varese | 21100 | Italy |
| Vedano Olona | Varese | 21040 | Italy |
| Vergiate | Varese | 21029 | Italy |
| Albano Sant'Alessandro | 24061 | Italy |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |