Pharyngitis Clinical Trial
— TarotOfficial title:
Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain
Verified date | December 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 177 |
Est. completion date | April 6, 2012 |
Est. primary completion date | April 5, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale | Up to two hours | ||
Secondary | Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent) | Two hours postdose or immediately before the intake of rescue medication | ||
Secondary | Time to first perceptible relief (defined as the time when the subject presses the first stopwatch) | Up to two hours | ||
Secondary | Time weighted sum of pain intensity differences (PID) scores over first hour | Up to one hour | ||
Secondary | Time weighted sum of pain intensity differences (PID) scores over 2 hours | Up to two hours | ||
Secondary | Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief | Up to two hours |
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