Overview

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