Evaluate Onset of Action of a Fast Release Aspirin

Study Overview
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Brief Summary
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To compare the safety and efficacy (onset, duration of relief and overall efficacy) of a single dose of a fast release formulation of aspirin 1000 mg compared to acetaminophen 1000 mg and placebo for relief of pain following extraction of impacted third molars.

Official Title
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Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)
* Drug: Acetaminophen (Tylenol extra strength)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, ambulatory, male and female volunteers between 16 to 45 years of age Scheduled to undergo surgical removal of either two partial bony impactions or one full bony alone or in combination with a partial bony impaction, soft tissue impaction or erupted third molar. Maxillary third molars may be removed regardless of impaction level Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without vasoconstrictor and nitrous oxide No use of any analgesics, nonsteroidal anti-inflammatory drug (NSAIDs), aspirin, any other pain reliever over the counter (OTC ) or prescription, or herbal supplements within 5 days of surgery. Oral contraceptives, prophylactic antibiotics, pre-anesthetic medication, anesthesia during the procedure, or other routine medications to treat benign conditions that would not confound the evaluation of the investigational would be acceptable Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 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 and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects < 18 years of age must sign a written assent and have parental or guardian consent) Exclusion Criteria: History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drug (NSAIDs), acetaminophen, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the Investigator Current or past history of bleeding disorder(s) History of gastrointestinal bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding) Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the Investigator Females who are pregnant or lactating Positive alcohol breathalyzer test and/or positive urine drug or cotinine test prior to surgery

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)<br>* Single oral dose of fast release aspirin tablet 1000 mg (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 milliliter [mL]) between 1-4 hours post dental surgery.<br>|
| Active Comparator: Arm 2<br> | Drug: Acetaminophen (Tylenol extra strength)<br>* Single oral dose of acetaminophen (Tylenol extra strength) caplet 1000 mg (2 x 500 mg) and 2 placebo matching aspirin tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Single oral dose of placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) with a full glass of water (240 mL) between 1-4 hours post dental surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Meaningful Pain Relief (PR) |  | 0 to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Perceptible Pain Relief |  | 0 to 6 hours | 
| Time to First Perceptible Pain Relief Confirmed |  | 0 to 6 hours | 
| Pain Intensity at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing |  | 5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose | 
| Pain Relief at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing |  | 5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours After Dosing | 
| Pain Intensity Difference (PID) at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing |  | 5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours | 
| Summed Pain Intensity Differences (SPID) from Hour 0 through Hour 2, Hour 4 and Hour 6 |  | 0 - 6 hours post-dose | 
| Summed Total Pain Relief (TOTPAR) from Hour 0 through Hour 2, Hour 4 and Hour 6 |  | 0 to 6 hours post-dose | 
| Time to First use of Rescue Medication |  | 0 to 6 hours | 
| Cumulative Percentage of Subjects Taking Rescue Medication |  | 1, 2, 3, 4, 5, and 6 hours post-dose | 
| Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication |  | At 6 hours postdose or immediately before first use of rescue medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drugs, Investigational, Acetylsalicylic Acid, Aspirin, dental pain