Study Completed

Healthy Subjects

Bayer Identifier:

15529

ClinicalTrials.gov Identifier:

NCT01420094

EudraCT Number:

2014-005270-11

EU CT Number:

Not Available

Evaluate onset of action of a fast release aspirin

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

16 - 45 Years

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

Trial summary

Enrollment Goal

510

Trial Dates

June 2011 - September 2011

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Salt Lake City, 84124, United States

Primary Outcome

Time to Meaningful Pain Relief (PR)
Time Frame:
0 to 6 hours
Safety Issue:
No

Secondary Outcome

Time to First Perceptible Pain Relief
Time Frame:
0 to 6 hours
Safety Issue:
No
Time to First Perceptible Pain Relief Confirmed
Time Frame:
0 to 6 hours
Safety Issue:
No
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
Time Frame:
5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose
Safety Issue:
No
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
Time Frame:
5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours After Dosing
Safety Issue:
No
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
Time Frame:
5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours
Safety Issue:
No
Summed Pain Intensity Differences (SPID) from Hour 0 through Hour 2, Hour 4 and Hour 6
Time Frame:
0 - 6 hours post-dose
Safety Issue:
No
Summed Total Pain Relief (TOTPAR) from Hour 0 through Hour 2, Hour 4 and Hour 6
Time Frame:
0 to 6 hours post-dose
Safety Issue:
No
Time to First use of Rescue Medication
Time Frame:
0 to 6 hours
Safety Issue:
No
Cumulative Percentage of Subjects Taking Rescue Medication
Time Frame:
1, 2, 3, 4, 5, and 6 hours post-dose
Safety Issue:
No
Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication
Time Frame:
At 6 hours postdose or immediately before first use of rescue medication
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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