Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Common Cold, Pharyngitis, Tonsillitis

Intervention / Treatment
-----------------
* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
* Drug: Paracetamol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol<br>|
| Active Comparator: Arm 2<br> | Drug: Paracetamol<br>* Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol |  | For 6 hours after drug intake | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sore Throat