Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain
Status: | Completed |
---|---|
Conditions: | Cancer, Other Indications |
Therapuetic Areas: | Oncology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/9/2018 |
Start Date: | September 27, 2011 |
End Date: | April 6, 2012 |
Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain
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.
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
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