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

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

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.

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