Trial Condition(s):
Common Cold, Pharyngitis, Tonsillitis
Placebo and active controlled study to compare the efficacy of Aspirin and Paracetamol in treatment of sore throat associated with a common cold
Bayer Identifier:
11381
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Male and female patients - Onset of common cold within the past 5 days - Current sore throat - Confirmed presence of a tonsillo-pharyngitis
Exclusion Criteria
- Hypersensitivity to acetylsalicylic acid, salicylates, paracetamol, or any other NSAID - Pregnant or lactating women - History or acute state of peptic ulceration or gastrointestinal bleeding - History of bleeding tendency - History of asthma - Inability to breathe through the nose or a history of chronic mouth breathing - Other exclusion criteria may apply
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Cardiff, United Kingdom, CF1 3US | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B15 2SQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chorley, United Kingdom, PR7 1NY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Liverpool, United Kingdom, L22 0LG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Liverpool, United Kingdom, L1 9AD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M15 6SX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reading, United Kingdom, RG2 7AG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wigan, United Kingdom, WN6 9EW | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Double-blind, randomized, placebo-controlled, single dose, parallel group study evaluating efficacy and safety of 1000 mg Acetylsalicylic Acid and 1000 mg Paracetamol in adult patients with sore throat associated with a common cold
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to ParacetamolTimeframe: For 6 hours after drug intake
Secondary Outcome
- Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to PlaceboTimeframe: For 6 hours after drug intake
- Total pain relief of Acetylsalicylic Acid in comparison to ParacetamolTimeframe: For 6 hours after drug intake
- Total pain relief of Acetylsalicylic Acid in comparison to PlaceboTimeframe: For 6 hours after drug intake
- Evaluation of Upper Respiratory Tract Infection symtomsTimeframe: 2 hours after drug intake
- Adverse Event collectionTimeframe: Up to 17 days after Screening
Additional Information
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