Clinical trial NCT01122602: Evaluate Analgesic Efficacy of Fast Release Aspirin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Drugs, Investigational
Keywords: Aspirin
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to First Perceptible Pain Relief (PR)
timeFrame: 0 to 6 hours
measure: Time to First Perceptible Pain Relief Confirmed
timeFrame: 0 to 6 hours
Secondary outcomes:
measure: Time to meaningful pain relief
timeFrame: 0 to 6 hours
measure: Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
timeFrame: 10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours post-dose
measure: Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
timeFrame: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
measure: Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
timeFrame: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
measure: Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6
timeFrame: 0 - 6 hours post-dose
measure: Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6
timeFrame: 0-6 hours post-dose
measure: Time to First use of Rescue Medication
timeFrame: 0 to 6 hours
measure: Cumulative Percentage of Subjects Taking Rescue Medication
timeFrame: 1, 2, 3, 4, 5, and 6 hours post-dose
measure: Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication
timeFrame: At 6 hours postdose or immediately before first use of rescue medication
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: