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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011355-46 | EudraCT Number |
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The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.
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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, BAYE4465) | Drug | 2 Sachets of 500 mg Aspirin Complex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of nasal congestion and relief of pain | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve for nasal airflow conductance from baseline | 1h, 2h, 3h | |
| Sum of subjective nasal congestion intensity differences | 1h, 2h, 3h, 4h and 1, 2, 3 days | |
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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 |
|---|---|---|---|---|---|---|
| Cardiff | South Glamorgan | CF1 3US | United Kingdom |
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| Label | URL |
|---|---|
| Click here and search for EMA Websynopsis results | View source |
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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 |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Pseudoephedrine | Drug | 2 Sachets of 30 mg Pseudoephedrine |
|
| Placebo | Drug | Matching Placebo |
|
| Total subjective nasal congestion relief |
| 1h, 2h, 3h,4 h and 1, 2, 3 days |
| Global assessment of nasal congestion | 3 days |
| Global assessment of pain relief | 3 days |
| Sum of pain intensity differences | 1h, 2h, 3h, 4h and 1, 2, 3 days |
| Total pain relief | 1, 2, 3 days |
| Adverse Event collection and physical examination | 3 days |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| 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 |