Trial Condition(s):

Pharyngitis

Evaluate the time of pain relief of fast acting aspirin versus acetaminophen in subjects diagnosed with sore throat pain (Tarot)

Bayer Identifier:

15772

ClinicalTrials.gov Identifier:

NCT01453400

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
177
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Storrs, United States, 06269-2011

Status
Completed
 

Trial Design