Evaluate Analgesic Efficacy of Fast Release Aspirin



Status:Completed
Healthy:No
Age Range:16 - 45
Updated:12/20/2018
Start Date:April 29, 2010
End Date:August 6, 2010

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A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 650 mg in Postsurgical Dental Pain

The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of
fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg
(2 x 325 mg) and placebo in subjects with postsurgical dental pain.


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, NSAIDs (Nonsteroidal Anti-inflammatory Drugs), 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 NSAIDs (Nonsteroidal
Antiinflammatory Drugs), acetaminophen, opioid analgesics, and similar pharmacological
agents or components of the investigational products, including the placebo

- Lactose intolerance or have had hypersensitivity reactions to lactose containing
products

- 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 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 positive urine drug test prior to surgery
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