Pharyngitis
Conditions
Keywords
aspirin, acetylsalicylic acid, pharyngitis, sore throat
Brief 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.
Interventions
DRUGAcetylsalicylic Acid (Aspirin, BAY1019036) + placebo
Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets
DRUGAcetaminophen + placebo
Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets
DRUGPlacebo
Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale | Up to two hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Time to first perceptible relief (defined as the time when the subject presses the first stopwatch) | Up to two hours |
| Time weighted sum of pain intensity differences (PID) scores over first hour | Up to one hour |
| Time weighted sum of pain intensity differences (PID) scores over 2 hours | Up to two hours |
| Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief | Up to two hours |
Countries
United States
Outcome results
None listed