check_circleStudy 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
  • - 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)
  • - 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

StatusInstitutionLocation
Completed
Salt Lake City, 84124, United States

Primary Outcome

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

Secondary Outcome

  • Time to First Perceptible Pain Relief
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    No
  • Time to First Perceptible Pain Relief Confirmed
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    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
    date_rangeTime 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
    enhanced_encryption
    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
    date_rangeTime 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
    enhanced_encryption
    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
    date_rangeTime Frame:
    5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours
    enhanced_encryption
    Safety Issue:
    No
  • Summed Pain Intensity Differences (SPID) from Hour 0 through Hour 2, Hour 4 and Hour 6
    date_rangeTime Frame:
    0 - 6 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Summed Total Pain Relief (TOTPAR) from Hour 0 through Hour 2, Hour 4 and Hour 6
    date_rangeTime Frame:
    0 to 6 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Time to First use of Rescue Medication
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    No
  • Cumulative Percentage of Subjects Taking Rescue Medication
    date_rangeTime Frame:
    1, 2, 3, 4, 5, and 6 hours post-dose
    enhanced_encryption
    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
    date_rangeTime Frame:
    At 6 hours postdose or immediately before first use of rescue medication
    enhanced_encryption
    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
3

Additional Information

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