Drugs, InvestigationalPhase 3TAROTNCT01122602
Evaluate Analgesic Efficacy of Fast Release Aspirin
A Phase 3 study testing Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036) and Acetylsalicyclic acid (Aspirin, BAYE4465) in people with Drugs, Investigational, run by Bayer at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drugs, Investigational
- What is being tested?
- Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036) and Acetylsalicyclic acid (Aspirin, BAYE4465)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2010to 6 Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Austin, Texas, 78705
Study site
Salt Lake City, Utah, 84124
About this study
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
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.
- Conditions
- Drugs, Investigational
- Being tested
- Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036), Acetylsalicyclic acid (Aspirin, BAYE4465), Placebo
- Keywords
- Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)Drug
Single dose of fast acting aspirin 2 x 325 mg = 650 mg total
Acetylsalicyclic acid (Aspirin, BAYE4465)Drug
Single dose of regular aspirin 2 x 325 mg = 650 mg total
PlaceboDrug
Two placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036) |
| Arm 2 | Active comparator | Not described Receives: Drug: Acetylsalicyclic acid (Aspirin, BAYE4465) |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Perceptible Pain Relief (PR)
Measured: 0 to 6 hours
Time to First Perceptible Pain Relief Confirmed
Measured: 0 to 6 hours
Secondary outcomes (9)
Time to meaningful pain relief
Measured: 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
Measured: 10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours post-dose
Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
Measured: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
Measured: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6
Measured: 0 - 6 hours post-dose
Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6
Measured: 0-6 hours post-dose
Time to First use of Rescue Medication
Measured: 0 to 6 hours
Cumulative Percentage of Subjects Taking Rescue Medication
Measured: 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
Measured: At 6 hours postdose or immediately before first use of rescue medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study start29 Apr 2010
- Primary completion29 Jul 2010
- Study completion6 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drugs, InvestigationalStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122602
- Sponsor's protocol ID
- 15082
- Other IDs
- 2014-005278-12, 2014
- Acronym
- TAROT
- Status last verified
- Dec 2018
- First submitted
- 11 May 2010
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01122602
- Acronym / sponsor ID
- TAROT / 15082
- Conditions
- Drugs, Investigational
- Keywords
- Aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2010 (actual)
- Primary completion
- 29 Jul 2010 (actual)
- Study completion
- 6 Aug 2010 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036) |
| Arm 2 | Active comparator | Drug: Acetylsalicyclic acid (Aspirin, BAYE4465) |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)Single dose of fast acting aspirin 2 x 325 mg = 650 mg total | Drug | Arm 1 |
| Acetylsalicyclic acid (Aspirin, BAYE4465)Single dose of regular aspirin 2 x 325 mg = 650 mg total | Drug | Arm 2 |
| PlaceboTwo placebo tablets | Drug | Arm 3 |
Primary outcome
Time to First Perceptible Pain Relief (PR)
Time frame: 0 to 6 hours
Time to First Perceptible Pain Relief Confirmed
Time frame: 0 to 6 hours
9 secondary outcomes
Time to meaningful pain relief
Time frame: 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
Time frame: 10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours post-dose
Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
Time frame: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
Time frame: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
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: 0-6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036) and Acetylsalicyclic acid (Aspirin, BAYE4465) in people with Drugs, Investigational, run by Bayer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Perceptible Pain Relief (PR) (time frame: 0 to 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.