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

Bayer

Status and phase

Completed

Phase 3

Conditions

Pharyngitis

Treatments

Drug: Placebo

Drug: Acetaminophen + placebo

Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453400

15772

Details and patient eligibility

About

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.

Enrollment

177 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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