Evaluate Analgesic Efficacy of Fast Release Aspirin (TAROT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01122602
First received: May 11, 2010
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg (2 x 325 mg) and placebo in subjects with postsurgical dental pain.


Condition Intervention Phase
Drugs, Investigational
Drug: Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)
Drug: Acetylsalicyclic acid (Aspirin, BAYE4465)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 650 mg in Postsurgical Dental Pain

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • Time to meaningful pain relief [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Pain Intensity, Pain Intensity Difference (PID) and Pain Relief at 10, 20, 30, 40, 50, 60 minutes, and at 2, 3, 4, 5, 6, hours postdose [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Summed Pain Intensity Differences (SPID) 0-2: summed, time-weighted pain relief from 0-2 hours postdose [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Total Pain Relief (TOTPAR) 0-2: summed, time-weighted total pain relief from 0-2 hours postdose [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Summed Pain Intensity Differences (SPID) 0-4 summary scores [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Total pain relief (TOTPAR) 0-4 summary scores [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Summed Pain Intensity Differences (SPID) 0-6 summary scores [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Total pain relief (TOTPAR) 0-6 summary scores [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: April 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)
Single dose of fast acting aspirin 2 x 325 mg = 650 mg total
Active Comparator: Arm 2 Drug: Acetylsalicyclic acid (Aspirin, BAYE4465)
Single dose of regular aspirin 2 x 325 mg = 650 mg total
Placebo Comparator: Arm 3 Drug: Placebo
Two placebo tablets

  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, NSAIDs (Nonsteroidal Anti-inflammatory Drugs), 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 NSAIDs (Nonsteroidal Antiinflammatory Drugs), 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122602

Locations
United States, Texas
Austin, Texas, United States, 78705
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: NCT01122602     History of Changes
Other Study ID Numbers: 15082
Study First Received: May 11, 2010
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Aspirin

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

ClinicalTrials.gov processed this record on August 01, 2014