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Evaluate Onset of Action of a Fast Release Aspirin (TAROT compare)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420094
First Posted: August 19, 2011
Last Update Posted: January 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
July 27, 2011
August 19, 2011
January 15, 2016
June 2011
September 2011   (Final data collection date for primary outcome measure)
Time to Meaningful Pain Relief (PR) [ Time Frame: 0 to 6 hours ]
Time to meaningful pain relief [ Time Frame: up to 6 hours ]
Complete list of historical versions of study NCT01420094 on ClinicalTrials.gov Archive Site
  • Time to First Perceptible Pain Relief [ Time Frame: 0 to 6 hours ]
  • Time to First Perceptible Pain Relief Confirmed [ Time Frame: 0 to 6 hours ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Summed Pain Intensity Differences (SPID) from Hour 0 through Hour 2, Hour 4 and Hour 6 [ Time Frame: 0 - 6 hours post-dose ]
  • Summed Total Pain Relief (TOTPAR) from Hour 0 through Hour 2, Hour 4 and Hour 6 [ Time Frame: 0 to 6 hours post-dose ]
  • Time to First use of Rescue Medication [ Time Frame: 0 to 6 hours ]
  • Cumulative Percentage of Subjects Taking Rescue Medication [ Time Frame: 1, 2, 3, 4, 5, and 6 hours post-dose ]
  • 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 ]
  • Time to First Perceptible Pain Relief [ Time Frame: up to 6 hours ]
  • Time to first perceptible relief confirmed [ Time Frame: up to 6 hours ]
  • Pain Relief (PR) scores over each scheduled time points [ Time Frame: up to 6 hours ]
  • Sum of Pain Intensity Difference (PID) scores over each scheduled time points [ Time Frame: up to 6 hours ]
  • Time-weighted sum of Pain Intensity Relief (PID) scores [ Time Frame: up to 6 hours ]
  • Time-weighted Total Pain Relief (TOTPAR) scores [ Time Frame: up to 6 hours ]
  • Summed Pain Intensity Difference (SPID) 0-4 summary scores [ Time Frame: up to 6 hours ]
  • Summed Pain Intensity Difference (SPID) 0-6 summary scores [ Time Frame: up to 6 hours ]
  • Time to rescue medication [ Time Frame: up to 6 hours ]
  • The cumulative proportion taking rescue medication by time point [ Time Frame: up to 6 hours ]
  • Global assessment of pain relief at 6 hours post dose or immediately before the first intake of rescue medication [ Time Frame: up to 6 hours ]
Not Provided
Not Provided
 
Evaluate Onset of Action of a Fast Release Aspirin
Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Healthy Subjects
  • Drug: Acetylsalicyclic 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.
  • Drug: Acetaminophen (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.
  • Drug: Placebo
    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.
  • Experimental: Arm 1
    Intervention: Drug: Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)
  • Active Comparator: Arm 2
    Intervention: Drug: Acetaminophen (Tylenol extra strength)
  • Placebo Comparator: Arm 3
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 45 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01420094
15529
2014-005270-11 ( EudraCT Number )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP