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

• Status: Completed
• Trial end date: 2012-04-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Acetaminophen; Aspirin

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