Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain.

Official Title
-----------------
Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain

Conditions
-----------------
Pharyngitis

Intervention / Treatment
-----------------
* Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo
* Drug: Acetaminophen + placebo
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, ambulatory, male and female subjects ≥ 18 years of age Presence of sore throat due to upper respiratory tract infection (URTI) Onset of sore throat pain within six days of the screening period Baseline sore throat pain intensity score ≥ 60 mm on the Sore Throat Pain Intensity Scale Have a score ≥ 5 on the Tonsillopharyngitis Assessment Female subjects of childbearing potential who are currently sexually active must be using a medically acceptable form of birth control for at least one month prior to screening (three months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Nuvaring, Depo-Provera, or double-barrier and have a negative pregnancy test at screening/treatment period. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy. Understand the pain rating assessments Exclusion Criteria: History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs Use of any cold medication (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product Presence of cough that causes throat discomfort Presence of mouth-breathing or any respiratory condition that, in the Investigator's judgment, could compromise breathing Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies for which aspirin or acetaminophen is contraindicated Relevant concomitant disease such as medically uncontrolled asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than fifty percent obstruction History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory therapy. Current or past history of a bleeding disorder Self reported alcoholism or drug abuse within two years prior to screening or routine consumption of three or more alcohol containing beverages per day Habituation to analgesic drugs or tranquilizers (i.e., routine use of five or more times per week for greater than three weeks) Acute illness, local infection, or disease (other than URTI with pharyngeal infection) that can interfere with the conduct of the study Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug Has initiated treatment for depression within the past thirty days Females who are pregnant or lactating

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo<br>* Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets<br>|
| Active Comparator: Arm 2<br> | Drug: Acetaminophen + placebo<br>* Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale |  | Up to two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent) |  | Two hours postdose or immediately before the intake of rescue medication | 
| Time to first perceptible relief (defined as the time when the subject presses the first stopwatch) |  | Up to two hours | 
| Time weighted sum of pain intensity differences (PID) scores over first hour |  | Up to one hour | 
| Time weighted sum of pain intensity differences (PID) scores over 2 hours |  | Up to two hours | 
| Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief |  | Up to two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirin, acetylsalicylic acid, pharyngitis, sore throat