evaluate the time of pain relief of fast acting aspirin versus acetaminophen in subjects diagnosed with sore throat pain

Conditions: Pharyngitis

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.


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

Keywords: aspirin acetylsalicylic acid pharyngitis sore throat