PharyngitisPhase 3TarotNCT01453400
Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain
A Phase 3 study of Pharyngitis, run by Bayer at 1 site in United States.
Trial summary
This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2011to 6 Apr 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy, ambulatory, male and female subjects ≥ 18 years of age
- Presence of sore throat due to upper respiratory tract infection (URTI)
- Onset of sore throat pain within six days of the screening period
- Baseline sore throat pain intensity score ≥ 60 mm on the Sore Throat Pain Intensity Scale
- Have a score ≥ 5 on the Tonsillopharyngitis Assessment
- Female subjects of childbearing potential who are currently sexually active must be using a medically acceptable form of birth control for at least one month prior to screening (three 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/treatment period. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy.
- Understand the pain rating assessments
Who cannot join
- History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs
- Use of any "cold medication" (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product
- Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product
- Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product
- Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product
- Presence of cough that causes throat discomfort
Show all 17Show fewer
- Presence of mouth-breathing or any respiratory condition that, in the Investigator's judgment, could compromise breathing
- Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies for which aspirin or acetaminophen is contraindicated
- Relevant concomitant disease such as medically uncontrolled asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than fifty percent obstruction
- History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory therapy.
- Current or past history of a bleeding disorder
- Self reported alcoholism or drug abuse within two years prior to screening or routine consumption of three or more alcohol containing beverages per day
- Habituation to analgesic drugs or tranquilizers (i.e., routine use of five or more times per week for greater than three weeks)
- Acute illness, local infection, or disease (other than URTI with pharyngeal infection) that can interfere with the conduct of the study
- Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug
- Has initiated treatment for depression within the past thirty days
- Females who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain
This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain.
- Conditions
- Pharyngitis
- Being tested
- Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo, Acetaminophen + placebo, Placebo
- Keywords
- aspirin, acetylsalicylic acid, pharyngitis, sore throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid (Aspirin, BAY1019036) + placeboDrug
Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets
Acetaminophen + placeboDrug
Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets
PlaceboDrug
Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo |
| Arm 2 | Active comparator | Not described Receives: Drug: Acetaminophen + placebo |
| 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 from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale
Measured: Up to two hours
Secondary outcomes (5)
Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent)
Measured: Two hours postdose or immediately before the intake of rescue medication
Time to first perceptible relief (defined as the time when the subject presses the first stopwatch)
Measured: Up to two hours
Time weighted sum of pain intensity differences (PID) scores over first hour
Measured: Up to one hour
Time weighted sum of pain intensity differences (PID) scores over 2 hours
Measured: Up to two hours
Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief
Measured: Up to two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study start27 Sep 2011
- Primary completion5 Apr 2012
- Study completion6 Apr 2012
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 PharyngitisStudies 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
- 177 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
- NCT01453400
- Sponsor's protocol ID
- 15772
- Acronym
- Tarot
- Status last verified
- Dec 2018
- First submitted
- 13 Oct 2011
- Last updated
- 7 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 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain
- ClinicalTrials.gov ID
- NCT01453400
- Acronym / sponsor ID
- Tarot / 15772
- Conditions
- Pharyngitis
- Keywords
- aspirin, acetylsalicylic acid, pharyngitis, sore throat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2011 (actual)
- Primary completion
- 5 Apr 2012 (actual)
- Study completion
- 6 Apr 2012 (actual)
- First posted
- 17 Oct 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.
This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain.
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: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo |
| Arm 2 | Active comparator | Drug: Acetaminophen + placebo |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy, ambulatory, male and female subjects ≥ 18 years of age
- Presence of sore throat due to upper respiratory tract infection (URTI)
- Onset of sore throat pain within six days of the screening period
- Baseline sore throat pain intensity score ≥ 60 mm on the Sore Throat Pain Intensity Scale
- Have a score ≥ 5 on the Tonsillopharyngitis Assessment
Key exclusion criteria (17 listed)
- History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs
- Use of any "cold medication" (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product
- Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product
- Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product
- Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product
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 |
|---|---|---|
| Acetylsalicylic Acid (Aspirin, BAY1019036) + placeboSingle dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets | Drug | Arm 1 |
| Acetaminophen + placeboSingle dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets | Drug | Arm 2 |
| PlaceboSingle dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets | Drug | Arm 3 |
Primary outcome
Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale
Time frame: Up to two hours
5 secondary outcomes
Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent)
Time frame: Two hours postdose or immediately before the intake of rescue medication
Time to first perceptible relief (defined as the time when the subject presses the first stopwatch)
Time frame: Up to two hours
Time weighted sum of pain intensity differences (PID) scores over first hour
Time frame: Up to one hour
Time weighted sum of pain intensity differences (PID) scores over 2 hours
Time frame: Up to two hours
Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief
Time frame: Up to two hours
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 7 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.
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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
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 of Pharyngitis, 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 7 inclusion and 17 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 7 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 from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale (time frame: Up to two 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 NCT01453400, 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 7 Dec 2018.