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The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. The study is designed to develop a treatment method against sore throat associated with a common cold which will have more advantages for patients than the methods that are currently available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid (Aspirin, BAYE4465) | Drug | Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol | For 6 hours after drug intake |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo | For 6 hours after drug intake | |
| Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol | For 6 hours after drug intake |
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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 |
|---|---|---|---|---|---|---|
| Reading | Berkshire | RG2 7AG | United Kingdom | |||
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| Paracetamol | Drug | Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid |
|
| Placebo | Drug | Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol |
|
| Total pain relief of Acetylsalicylic Acid in comparison to Placebo | For 6 hours after drug intake |
| Evaluation of Upper Respiratory Tract Infection symtoms | 2 hours after drug intake |
| Adverse Event collection | Up to 17 days after Screening |
| Manchester |
| Greater Manchester |
| M15 6SX |
| United Kingdom |
| Chorley | Lancashire | PR7 1NY | United Kingdom |
| Wigan | Lancashire | WN6 9EW | United Kingdom |
| Liverpool | Merseyside | L1 9AD | United Kingdom |
| Liverpool | Merseyside | L22 0LG | United Kingdom |
| Cardiff | South Glamorgan | CF1 3US | United Kingdom |
| Birmingham | West Midlands | B15 2SQ | United Kingdom |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D010612 | Pharyngitis |
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| 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 |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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