check_circleStudy Completed

Drugs, Investigational

Bayer Identifier:

15120

ClinicalTrials.gov Identifier:

NCT01117636

EudraCT Number:

2014-005271-81

EU CT Number:

Not Available
Evaluate analgesic efficacy of fast release Aspirin

Trial purpose

The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000 mg (2 x 500 mg) and placebo in subjects with postsurgical dental pain.

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
    - 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 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 positive urine drug test prior to surgery

Trial summary

Enrollment Goal
514
Trial Dates
April 2010 - July 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Austin, 78744, United States
Completed
Salt Lake City, 84106, United States

Primary Outcome

  • Time to First Perceptible Pain Relief (PR)
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    no
  • Time to First Perceptible Pain Relief (PR) Confirmed
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to Meaningful Pain Relief (PR)
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    no
  • Pain Intensity at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing
    Pain Intensity (PI) was rated by subjects on a 4-point Categorical Pain Intensity Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose.
    date_rangeTime Frame:
    10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours postdose
    enhanced_encryption
    Safety Issue:
    no
  • Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing
    Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose. For each post-dose time point, PID was derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement.
    date_rangeTime Frame:
    10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose
    enhanced_encryption
    Safety Issue:
    no
  • Pain Relief at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing
    Pain relief was rated by subjects using a 5-point Categorical Relief Rating Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
    date_rangeTime Frame:
    10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose
    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 to 6 hours postdose
    enhanced_encryption
    Safety Issue:
    No
  • Summed Total Pain Relief (TOTPAR) From Hour 0 Through Hour 2, Hour 4 and Hour 6
    date_rangeTime Frame:
    0-6 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 postdose
    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

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 1000 mg in Postsurgical Dental Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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