Pain, MigrainePhase 4NCT01248468

Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine

A Phase 4 study testing Aspirin, acetaminophen and caffeine and Sumatriptan in people with Pain, Migraine, run by Novartis at 20 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 main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Migraine
What is being tested?: Aspirin, acetaminophen and caffeine and Sumatriptan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 752 participants
Where: 20 sitesUnited States
Study dates: Nov 2010to Mar 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female aged 18 years and over.
International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
History of at least moderate migraine pain intensity, if left untreated.

Who cannot join

Headache symptoms which may be due to or aggravated by:
Recent (within 6 months) head or neck trauma (e.g., whiplash)
Head or neck pain secondary to an orthopedic abnormality
Cluster headache
Specific migraine variants (e.g., basilar-type artery migraine, ophthalmoplegic migraine, hemiplegic migraine, migraine aura without headache)
Other serious, non-migraine causes of headache (e.g., increased intracranial pressure, intracranial bleeding, meningitis, malignancy)

Show all 10Show fewer

Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)
Routine use (≥ 10 days per month, on average) of any medication having the potential to interfere with the pharmacologic effects or evaluation of the study medications (e.g., narcotic and non-narcotic analgesic products (prescription or over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics, hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs).
History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Anaheim, California
Study site
Ann Arbor, Michigan
Study site
Chicago, Illinois
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
DeLand, Florida
Study site
Jacksonville, Florida
Study site
Miami, Florida
Study site
Mt. Pleasant, South Carolina
Study site
Nashville, Tennessee
Study site
Pembroke Pines, Florida
Study site
Raleigh, North Carolina
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Springfield, Missouri
Study site
The Bronx, New York
Study site
West Palm Beach, Florida

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel-group Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine.

The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.

Conditions: Pain, Migraine
Being tested: Aspirin, acetaminophen and caffeine, Sumatriptan, Placebo
Keywords: Pain, Migraine
Medical subject headings: Pain, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aspirin, acetaminophen and caffeineDrug
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
SumatriptanDrug
100 mg Sumatriptan
PlaceboDrug
placebo

Study groups in NCT01248468
Study group	Role	What they receive
Aspirin, acetaminophen and caffeine	Experimental	AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets Receives: Drug: Aspirin, acetaminophen and caffeine
Sumatriptan (100 mg)	Active comparator	1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets Receives: Drug: Sumatriptan
Placebo	Placebo comparator	1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets Receives: Drug: Placebo

What is being measured

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

Percent of Subjects Who Are Pain Free at 2 Hours.
Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours
Measured: 2 hours

Secondary outcomes (3)

Percent of Subjects Who Are Free of Nausea at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Measured: 2 hours
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Measured: 2 hours
Percent of Subjects Who Are Free of Photophobia at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Mar 2011

First posted25 Nov 2010 (estimated)
Study startNov 2010
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain, MigraineStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 752 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01248468
Sponsor's protocol ID: 176-P-401
Status last verified: Jun 2012
First submitted: 23 Nov 2010
Last updated: 30 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Parallel-group Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine.
ClinicalTrials.gov ID: NCT01248468
Acronym / sponsor ID: 176-P-401
Conditions: Pain, Migraine
Keywords: Pain, Migraine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 752 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 25 Nov 2010 (estimated)
Results: Posted 30 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Aspirin, acetaminophen and caffeine	Experimental	Drug: Aspirin, acetaminophen and caffeineAAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
Sumatriptan (100 mg)	Active comparator	Drug: Sumatriptan1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Placebo	Placebo comparator	Drug: Placebo1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female aged 18 years and over.
International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
History of at least moderate migraine pain intensity, if left untreated.

Key exclusion criteria (10 listed)

Headache symptoms which may be due to or aggravated by:
Routine use (≥ 10 days per month, on average) of any medication having the potential to interfere with the pharmacologic effects or evaluation of the study medications (e.g., narcotic and non-narcotic analgesic products (prescription or over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics, hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs).
History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes.
Other protocol-defined inclusion/exclusion criteria may apply

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
Aspirin, acetaminophen and caffeine2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)	Drug	Aspirin, acetaminophen and caffeine
Sumatriptan100 mg Sumatriptan	Drug	Sumatriptan (100 mg)
Placeboplacebo	Drug	Placebo

Primary outcome

Percent of Subjects Who Are Pain Free at 2 Hours.
Time frame: 2 hours
Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours

3 secondary outcomes

Percent of Subjects Who Are Free of Nausea at 2 Hours.
Time frame: 2 hours
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
Time frame: 2 hours
Percent of Subjects Who Are Free of Photophobia at 2 Hours.
Time frame: 2 hours

Results and safety

Results posted to the registry on 30 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aspirin, Acetaminophen, and Caffeine	299	284
Sumatriptan (100 mg)	304	290
Placebo	149	145

Primary outcome: Percent of Subjects Who Are Pain Free at 2 Hours.

Time frame: 2 hours. Number. Unit: Percent of participants

Measure	Aspirin, Acetaminophen, and Caffeine n = 248	Sumatriptan (100 mg) n = 256	Placebo n = 121
Value	34.7 (.938 to 2.484)	44.9 (0.431 to .900)	26.4 (1.525 to 3.937)

Population analysed: The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Instead, missing values were implicitly imputed by the repeated measures analysis statistical model. So, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aspirin, Acetaminophen, and Caffeine	0 of 266 (0%)	8 of 266 (3%)	Not reported
Sumatriptan (100 mg)	0 of 271 (0%)	14 of 271 (5.2%)	Not reported
Placebo	0 of 133 (0%)	3 of 133 (2.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
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Recruiting
Marine Lipids Ease Painful TMD
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Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
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Enrolling by invitation
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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.

Clinical Project Leader study director

Novartis Consumer Health

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin, acetaminophen and caffeine and Sumatriptan in people with Pain, Migraine, run by Novartis at 20 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 4 inclusion and 10 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 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent of Subjects Who Are Pain Free at 2 Hours. (time frame: 2 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 NCT01248468.

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 30 Jul 2012.