HeadachePhase 3Tarot HeadacheNCT01552798
Efficacy of a Single Dose of Aspirin vs. Acetaminophen in Tension Type Headache
A Phase 3 study testing Acetylsalicylic acid (Aspirin, BAY1019036) and Acetaminophen in people with Headache, run by Bayer at 1 site in United States.
Trial summary
The purpose of this trial is to determine if a single, oral dose of a fast release aspirin 1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with tension-type headache pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- Acetylsalicylic acid (Aspirin, BAY1019036) and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2012to 4 Jun 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, ambulatory, male and female volunteers ages 18-65 years old
- History of an onset of tension type headaches before age 50
- Experiencing over the last year ≥ 4 tension type headaches of at least moderate intensity per month and with the majority of headaches lasting greater than three hours, that meet commonly recognized criteria for diagnosis per the International Headache Society
- History of response to treatment with over-the-counter (OTC) analgesics
- Understand the pain rating scales (as judged by the trial coordinator)
- Present with at least moderate headache pain on a 0-10 point numerical rating scale (a score of at least 4 on an 11 point scale ranging from 0 to 10) at the Treatment Visit
- Onset of pain within three hours of the Treatment Visit
- Confirmation by a physician of acute tension type headache symptoms as described by the International Headache Society diagnostic criteria
Who cannot join
- History of hypersensitivity to aspirin, salicylates, other NSAIDs, acetaminophen, and similar pharmacological agents or components of the investigational products, including the placebo
- Use of any immediate release analgesic/anti-pyretic within four hours or use of any sustained release or long acting analgesic/anti-pyretic within 12 hours proceeding administration of Investigational Product
- Presence of symptoms that are consistent with menstrual headache or migraine headache as described by the International Headache Society diagnostic criteria
- History of migraine headaches more than once per month
- 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 trial in the judgment of the Investigator
- Current or past history of bleeding disorder(s)
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- History of gastrointestinal bleeding or perforation, related to previous Nonsteroidal Anti-inflammatory Drugs (NSAID) therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Recent head or neck trauma (within 2 weeks)
- Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug
Trial locations and contacts
1 site in 1 country.
United States1 site
Westside Family Medical Center
Kalamazoo, Michigan, 49009
About this study
Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single Dose of Fast Release Aspirin 1000 mg and Acetaminophen 1000 mg in Tension Type Headache Pain
The purpose of this trial is to determine if a single, oral dose of a fast release aspirin 1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with tension-type headache pain.
- Conditions
- Headache
- Being tested
- Acetylsalicylic acid (Aspirin, BAY1019036), Acetaminophen, Placebo
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid (Aspirin, BAY1019036)Drug
2 x 500 mg fast release aspirin tablets (1000 mg) and 2 x placebo acetaminophen caplets
AcetaminophenDrug
2 x 500 mg acetaminophen caplets (1000 mg) and 2 x placebo fast release aspirin tablets
PlaceboDrug
2 x placebo acetaminophen caplets and 2 x placebo fast release aspirin tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicylic acid (Aspirin, BAY1019036) |
| Arm 2 | Active comparator | Not described Receives: Drug: Acetaminophen |
| 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 (defined as the time when the subject indicates pain relief that is meaningful to the subject)
Measured: Up to 2 hours post-dose
Secondary outcomes (14)
Time to first perceptible relief
Is defined as the time when the subject presses the first stopwatch
Measured: Up to 2 hours post-dose
Time to first perceptible relief confirmed
The subjects would meet this outcome if they answer "yes" when asked directly after stopping the first stopwatch, if they marked a "1" on the relief pain scale or if they stopped the 2nd stop watch.
Measured: Up to 2 hours post-dose
Change from baseline in pain intensity score at different time points (on an 11-point Categorical Pain Intensity Scale, 0 = no pain, 10 = severe pain)
Measured: At baseline, 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication
Pain Relief on 5-point Categorical Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, and 4 = complete relief)
Measured: At 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication
Summed time weighted of Pain Intensity Differences (PID) scores over first hour (SPID0-1)
Measured: Up to 1 hour
Summed time weighted of Pain Intensity Differences (PID) scores over 2 hours (SPID0-2)
Measured: Up to 2 hours
Summed time weighted total pain relief scores over first hour (TOTPAR0-1)
Measured: Up to 1 hour
Summed time weighted of Total Pain Relief Scores (TOTPAR) scores over 2 hours (TOTPAR0-2)
Measured: Up to 2 hours
Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over first hour (SPRID0-1)
Measured: Up to 1 hour
Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over 2 hours (SPRID0-2)
Measured: Up to 2 hours
Time to first intake of rescue medication
Measured: Up to 2 hours
Cumulative proportion of subjects taking rescue medication by time point
Measured: Up to 2 hours
Global assessment of the investigational product as a pain reliever: 0 = poor, 1 = fair, 2 = good, 3 = very good or 4 = excellent
Measured: At 2 hours post-dose or immediately before the first intake of rescue medication, whichever is earlier
Safety variable will be summarized using descriptive statistic based on adverse events collection
Measured: Up to 5 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study start12 Mar 2012
- Primary completion4 Jun 2012
- Study completion4 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- 9 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
- NCT01552798
- Sponsor's protocol ID
- 15771
- Acronym
- Tarot Headache
- Status last verified
- Dec 2018
- First submitted
- 9 Mar 2012
- 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 Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single Dose of Fast Release Aspirin 1000 mg and Acetaminophen 1000 mg in Tension Type Headache Pain
- ClinicalTrials.gov ID
- NCT01552798
- Acronym / sponsor ID
- Tarot Headache / 15771
- Conditions
- Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2012 (actual)
- Primary completion
- 4 Jun 2012 (actual)
- Study completion
- 4 Jun 2012 (actual)
- First posted
- 13 Mar 2012 (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 purpose of this trial is to determine if a single, oral dose of a fast release aspirin 1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with tension-type headache 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) |
| Arm 2 | Active comparator | Drug: Acetaminophen |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy, ambulatory, male and female volunteers ages 18-65 years old
- History of an onset of tension type headaches before age 50
- Experiencing over the last year ≥ 4 tension type headaches of at least moderate intensity per month and with the majority of headaches lasting greater than three hours, that meet commonly recognized criteria for diagnosis per the International Headache Society
- History of response to treatment with over-the-counter (OTC) analgesics
- Understand the pain rating scales (as judged by the trial coordinator)
Key exclusion criteria (9 listed)
- History of hypersensitivity to aspirin, salicylates, other NSAIDs, acetaminophen, and similar pharmacological agents or components of the investigational products, including the placebo
- Use of any immediate release analgesic/anti-pyretic within four hours or use of any sustained release or long acting analgesic/anti-pyretic within 12 hours proceeding administration of Investigational Product
- Presence of symptoms that are consistent with menstrual headache or migraine headache as described by the International Headache Society diagnostic criteria
- History of migraine headaches more than once per month
- 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 trial in the judgment of the Investigator
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)2 x 500 mg fast release aspirin tablets (1000 mg) and 2 x placebo acetaminophen caplets | Drug | Arm 1 |
| Acetaminophen2 x 500 mg acetaminophen caplets (1000 mg) and 2 x placebo fast release aspirin tablets | Drug | Arm 2 |
| Placebo2 x placebo acetaminophen caplets and 2 x placebo fast release aspirin tablets | Drug | Arm 3 |
Primary outcome
Time to meaningful pain relief (defined as the time when the subject indicates pain relief that is meaningful to the subject)
Time frame: Up to 2 hours post-dose
14 secondary outcomes
Time to first perceptible relief
Time frame: Up to 2 hours post-dose
Time to first perceptible relief confirmed
Time frame: Up to 2 hours post-dose
Change from baseline in pain intensity score at different time points (on an 11-point Categorical Pain Intensity Scale, 0 = no pain, 10 = severe pain)
Time frame: At baseline, 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication
Pain Relief on 5-point Categorical Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, and 4 = complete relief)
Time frame: At 30, 60, 90 and 120 minutes post-dose, and immediately prior to the use of any rescue medication
Summed time weighted of Pain Intensity Differences (PID) scores over first hour (SPID0-1)
Time frame: Up to 1 hour
Summed time weighted of Pain Intensity Differences (PID) scores over 2 hours (SPID0-2)
Time frame: Up to 2 hours
Summed time weighted total pain relief scores over first hour (TOTPAR0-1)
Time frame: Up to 1 hour
Summed time weighted of Total Pain Relief Scores (TOTPAR) scores over 2 hours (TOTPAR0-2)
Time frame: Up to 2 hours
Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over first hour (SPRID0-1)
Time frame: Up to 1 hour
Summed, time weighted of Pain Relief and Pain Intensity Differences (PID) over 2 hours (SPRID0-2)
Time frame: Up to 2 hours
Time to first intake of rescue medication
Time frame: Up to 2 hours
Cumulative proportion of subjects taking rescue medication by time point
Time frame: Up to 2 hours
Global assessment of the investigational product as a pain reliever: 0 = poor, 1 = fair, 2 = good, 3 = very good or 4 = excellent
Time frame: At 2 hours post-dose or immediately before the first intake of rescue medication, whichever is earlier
Safety variable will be summarized using descriptive statistic based on adverse events collection
Time frame: Up to 5 days post-dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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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 testing Acetylsalicylic acid (Aspirin, BAY1019036) and Acetaminophen in people with Headache, 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 8 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: stopped early, 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 was stopped early. Results are not available in the source record.
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 (defined as the time when the subject indicates pain relief that is meaningful to the subject) (time frame: Up to 2 hours post-dose). 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.