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CompletedNCT01420094TAROT compareUpdated Dec 19, 2018

Evaluate Onset of Action of a Fast Release Aspirin

A Phase 3 interventional study of Acetylsalicyclic acid (Fast release Aspirin, BAY1019036) and Acetaminophen (Tylenol extra strength) in Healthy Subjects, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
510
Allocation
Randomized
Ages
16 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Drugs, Investigational
  • Acetylsalicylic Acid
  • Aspirin
  • dental pain
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
510 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

  • Active comparator
    Arm 2

    Drug: Acetaminophen (Tylenol extra strength)

  • Placebo comparator
    Arm 3

    Drug: Placebo

Interventions

  • DrugAcetylsalicyclic acid (Fast release Aspirin, BAY1019036)

    Single oral dose of fast release aspirin tablet 1000 mg (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 milliliter \[mL\]) between 1-4 hours post dental surgery.

  • DrugAcetaminophen (Tylenol extra strength)

    Single oral dose of acetaminophen (Tylenol extra strength) caplet 1000 mg (2 x 500 mg) and 2 placebo matching aspirin tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

  • DrugPlacebo

    Single oral dose of placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

06

What researchers measure

Primary outcomes

  1. Time to Meaningful Pain Relief (PR)

    Time frame: 0 to 6 hours

Secondary outcomes

  1. Time to First Perceptible Pain Relief

    Time frame: 0 to 6 hours

  2. Time to First Perceptible Pain Relief Confirmed

    Time frame: 0 to 6 hours

  3. 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

  4. 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

  5. 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

  6. Summed Pain Intensity Differences (SPID) from Hour 0 through Hour 2, Hour 4 and Hour 6

    Time frame: 0 - 6 hours post-dose

  7. Summed Total Pain Relief (TOTPAR) from Hour 0 through Hour 2, Hour 4 and Hour 6

    Time frame: 0 to 6 hours post-dose

  8. Time to First use of Rescue Medication

    Time frame: 0 to 6 hours

  9. Cumulative Percentage of Subjects Taking Rescue Medication

    Time frame: 1, 2, 3, 4, 5, and 6 hours post-dose

  10. 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

07

Study locations

1 site
  • Salt Lake City, Utah 84124, United States
08

References and documents

Publications

  • Voelker M, Schachtel BP, Cooper SA, Gatoulis SC. Efficacy of disintegrating aspirin in two different models for acute mild-to-moderate pain: sore throat pain and dental pain. Inflammopharmacology. 2016 Feb;24(1):43-51. doi: 10.1007/s10787-015-0253-0. Epub 2015 Nov 24. PubMed 26603742 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01420094
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Aug 19, 2011
Start date
Jun 16, 2011
Primary completion
Sep 8, 2011
Completion
Sep 8, 2011
Last update
Dec 19, 2018

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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