Evaluate Analgesic Efficacy of Fast Release Aspirin (TAROT)

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

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.

Study Overview

• Status: Completed
• Conditions: Drugs, Investigational
• Intervention / Treatment: Drug: Acetylsalicylic acid (Fast release Aspirin, BAY1019036); Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 514
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
  • Utah
    • Salt Lake City, Utah, United States, 84106

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Drug: Acetylsalicylic acid (Fast release Aspirin, BAY1019036); Single oral dose of fast release aspirin tablets 1000 mg (2 x 500 mg) with a full glass of water (240 milliliter [mL]) between 14 hours post dental surgery.
ACTIVE_COMPARATOR: Arm 2	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 14 hours post dental surgery.
PLACEBO_COMPARATOR: Arm 3	Drug: Placebo; Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 14 hours post dental surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to First Perceptible Pain Relief (PR)	0 to 6 hours
Time to First Perceptible Pain Relief (PR) Confirmed	0 to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First use of Rescue Medication		0 to 6 hours
Time to Meaningful Pain Relief (PR)		0 to 6 hours
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.	10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours postdose
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.	10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose
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).	10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose
Summed Pain Intensity Differences (SPID) From Hour 0 Through Hour 2, Hour 4 and Hour 6		0 to 6 hours postdose
Summed Total Pain Relief (TOTPAR) From Hour 0 Through Hour 2, Hour 4 and Hour 6		0-6 hours post-dose
Cumulative Percentage of Subjects Taking Rescue Medication		1, 2, 3, 4, 5, and 6 hours postdose
Global Assessment of the Investigational Product as a Pain Reliever at 6 Hours After Dosing or Immediately Before the First Intake of Rescue Medication		At 6 hours postdose or immediately before first use of rescue medication

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2010
• Primary Completion (ACTUAL): July 7, 2010
• Study Completion (ACTUAL): July 7, 2010

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (ESTIMATE): May 5, 2010

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Aspirin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 15120; 2014-005271-81 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No