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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01420094
First received: July 27, 2011
Last updated: October 12, 2013
Last verified: October 2013
  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.


Condition Intervention Phase
Healthy Subjects
Drug: Acetylsalicylic Acid (Aspirin, BAY1019036)
Drug: Acetaminophen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to meaningful pain relief [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first perceptible pain relief [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Time to first perceptible relief confirmed [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Pain Relief (PR) scores over each scheduled time points [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Sum of Pain Intensity Difference (PID) scores over each scheduled time points [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Time-weighted sum of Pain Intensity Relief (PID) scores [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Time-weighted Total Pain Relief (TOTPAR) scores [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Summed Pain Intensity Difference (SPID) 0-4 summary scores [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Summed Pain Intensity Difference (SPID) 0-6 summary scores [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Time to rescue medication [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • The cumulative proportion taking rescue medication by time point [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 510
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acetylsalicylic Acid (Aspirin, BAY1019036)
Single dose of Fast Release Aspirin: 2 x 500 mg tablet (1000 mg total) and 2 placebo matching acetaminophen caplets
Active Comparator: Arm 2 Drug: Acetaminophen
Acetaminophen (Tylenol Extra Strength): 2 x 500 mg caplet (1000 mg total) and 2 placebo matching aspirin tablets
Placebo Comparator: Arm 3 Drug: Placebo
2 placebo aspirin tablets and 2 placebo acetaminophen caplets

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01420094

Locations
United States, Utah
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01420094     History of Changes
Other Study ID Numbers: 15529
Study First Received: July 27, 2011
Last Updated: October 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Drugs, Investigational
Acetylsalicylic Acid
Aspirin
dental pain

Additional relevant MeSH terms:
Acetaminophen
Aspirin
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014