Healthy SubjectsPhase 3TAROT compareNCT01420094
Evaluate Onset of Action of a Fast Release Aspirin
A Phase 3 study testing Acetylsalicyclic acid (Fast release Aspirin, BAY1019036) and Acetaminophen (Tylenol extra strength) in people with Healthy Subjects, run by Bayer at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Acetylsalicyclic acid (Fast release Aspirin, BAY1019036) and Acetaminophen (Tylenol extra strength)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2011to 8 Sep 2011
- 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, 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Subjects
- Being tested
- Acetylsalicyclic acid (Fast release Aspirin, BAY1019036), Acetaminophen (Tylenol extra strength), Placebo
- Keywords
- Drugs, Investigational, Acetylsalicylic Acid, Aspirin, dental pain
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)Drug
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.
Acetaminophen (Tylenol extra strength)Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicyclic acid (Fast release Aspirin, BAY1019036) |
| Arm 2 | Active comparator | Not described Receives: Drug: Acetaminophen (Tylenol extra strength) |
| 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 Meaningful Pain Relief (PR)
Measured: 0 to 6 hours
Secondary outcomes (10)
Time to First Perceptible Pain Relief
Measured: 0 to 6 hours
Time to First Perceptible Pain Relief Confirmed
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0 - 6 hours post-dose
Summed Total Pain Relief (TOTPAR) from Hour 0 through Hour 2, Hour 4 and Hour 6
Measured: 0 to 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 posted19 Aug 2011 (estimated)
- Study start16 Jun 2011
- Primary completion8 Sep 2011
- Study completion8 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 510 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
- NCT01420094
- Sponsor's protocol ID
- 15529
- Other IDs
- 2014-005270-11, 2014
- Acronym
- TAROT compare
- Status last verified
- Dec 2018
- First submitted
- 27 Jul 2011
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26603742
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
- Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model
- ClinicalTrials.gov ID
- NCT01420094
- Acronym / sponsor ID
- TAROT compare / 15529
- Conditions
- Healthy Subjects
- Keywords
- Drugs, Investigational, Acetylsalicylic Acid, Aspirin, dental pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2011 (actual)
- Primary completion
- 8 Sep 2011 (actual)
- Study completion
- 8 Sep 2011 (actual)
- First posted
- 19 Aug 2011 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Acetylsalicyclic acid (Fast release Aspirin, BAY1019036) |
| Arm 2 | Active comparator | Drug: Acetaminophen (Tylenol extra strength) |
| 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, 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
Key exclusion criteria (8 listed)
- 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)
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 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 | Arm 1 |
| 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 | Arm 2 |
| PlaceboSingle 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. | Drug | Arm 3 |
Primary outcome
Time to Meaningful Pain Relief (PR)
Time frame: 0 to 6 hours
10 secondary outcomes
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
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.
- Derived from this study: PubMed 26603742Voelker 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.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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
1 site 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 release Aspirin, BAY1019036) and Acetaminophen (Tylenol extra strength) in people with Healthy Subjects, run by Bayer at 1 site 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 8 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 1 site 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 Meaningful Pain Relief (PR) (time frame: 0 to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420094, which also lists 1 linked publication.
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.