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Drugs, InvestigationalPhase 3TAROTNCT01117636

Evaluate Analgesic Efficacy of Fast Release Aspirin

A Phase 3 study testing Acetylsalicylic acid (Fast release Aspirin, BAY1019036) and Acetylsalicylic Acid (Aspirin, BAYE4465) in people with Drugs, Investigational, run by Bayer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 45 years
Conditions the study is for
Drugs, Investigational
What is being tested?
Acetylsalicylic acid (Fast release Aspirin, BAY1019036) and Acetylsalicylic 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
514 participants
Where
2 sitesUnited States
Study dates
28 Apr 2010to 7 Jul 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
  • No healthy volunteers
  • 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
  • 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)
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  • 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, 78744

  • Study site

    Salt Lake City, Utah, 84106

Other trials in United States

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 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.

Being tested
Acetylsalicylic acid (Fast release Aspirin, BAY1019036), Acetylsalicylic 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.

  • Acetylsalicylic acid (Fast release Aspirin, BAY1019036)Drug

    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.

  • Acetylsalicylic Acid (Aspirin, BAYE4465)Drug

    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.

  • PlaceboDrug

    Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 14 hours post dental surgery.

Study groups in NCT01117636
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Acetylsalicylic acid (Fast release Aspirin, BAY1019036)
Arm 2Active comparatorNot described
Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Arm 3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Perceptible Pain Relief (PR)

    Measured: 0 to 6 hours

  2. Time to First Perceptible Pain Relief (PR) Confirmed

    Measured: 0 to 6 hours

Secondary outcomes (9)

  1. Time to Meaningful Pain Relief (PR)

    Measured: 0 to 6 hours

  2. 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.

    Measured: 10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours postdose

  3. 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.

    Measured: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose

  4. 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).

    Measured: 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose

  5. Summed Pain Intensity Differences (SPID) From Hour 0 Through Hour 2, Hour 4 and Hour 6

    Measured: 0 to 6 hours postdose

  6. Summed Total Pain Relief (TOTPAR) From Hour 0 Through Hour 2, Hour 4 and Hour 6

    Measured: 0-6 hours post-dose

  7. Time to First use of Rescue Medication

    Measured: 0 to 6 hours

  8. Cumulative Percentage of Subjects Taking Rescue Medication

    Measured: 1, 2, 3, 4, 5, and 6 hours postdose

  9. 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.

  1. First posted5 May 2010 (estimated)
  2. Study start28 Apr 2010
  3. Primary completion7 Jul 2010
  4. Study completion7 Jul 2010

Resources

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01117636
Sponsor's protocol ID
15120
Other IDs
2014-005271-81, 2014
Acronym
TAROT
Status last verified
Dec 2018
First submitted
4 May 2010
Last updated
19 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetylsalicylic acid (Fast release Aspirin, BAY1019036) and Acetylsalicylic 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?

On the ClinicalTrials.gov record for NCT01117636.

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.

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