Evaluate Onset of Action of a Fast Release Aspirin
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 16 - 45 |
Updated: | 12/20/2018 |
Start Date: | June 16, 2011 |
End Date: | September 8, 2011 |
Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model
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.
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.
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
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