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:

NCT01465009

EudraCT Number:

Not Available

Study Completed

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
508
Trial Dates
black-arrow
Phase
IV
Could I receive a placebo?
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Cardiff, United Kingdom, CF1 3US

Status
Completed
 
Locations

Investigative Site

Birmingham, United Kingdom, B15 2SQ

Status
Completed
 
Locations

Investigative Site

Chorley, United Kingdom, PR7 1NY

Status
Completed
 
Locations

Investigative Site

Liverpool, United Kingdom, L22 0LG

Status
Completed
 
Locations

Investigative Site

Liverpool, United Kingdom, L1 9AD

Status
Completed
 
Locations

Investigative Site

Manchester, United Kingdom, M15 6SX

Status
Completed
 
Locations

Investigative Site

Reading, United Kingdom, RG2 7AG

Status
Completed
 
Locations

Investigative Site

Wigan, United Kingdom, WN6 9EW

Status
Completed
 

Trial Design