CompletedNCT01248468Updated Jul 30, 2012Results posted

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

A Phase 4 interventional study of Aspirin, acetaminophen and caffeine and Sumatriptan in Pain, Migraine, sponsored by Novartis. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-30.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 752
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Pain, Migraine

Browse trials for

Migraine Disorders 1,528

Keywords

Pain, Migraine

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 752 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

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)
- 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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 752 participants (actual)

Study arms

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

Interventions

DrugAspirin, acetaminophen and caffeine
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
DrugSumatriptan
100 mg Sumatriptan
DrugPlacebo
placebo

What researchers measure

Primary outcomes

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
Time frame: 2 hours

Secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 2 hours

Results

Posted Jul 30, 2012

Participant flow

Participant flow — Overall Study
Milestone	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo
Started	299	304	149
Safety population	266	271	133
Itt population	256	261	125
Completed	284	290	145
Not completed	15	14	4
Withdrew: Administrative problem	1	0	0
Withdrew: Lost to follow-up	9	12	4
Withdrew: Pregnancy	1	0	0
Withdrew: Withdrawal by subject	4	2	0

Outcome measures

PrimaryPercent 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

Time frame:: 2 hours
Reported as:: Number · Percent of participants

Percent of Subjects Who Are Pain Free at 2 Hours.
Percent of participants	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo
Percent of Subjects Who Are Pain Free at 2 Hours.	34.7 (.938 to 2.484)	44.9 (0.431 to .900)	26.4 (1.525 to 3.937)

SecondaryPercent 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

Time frame:: 2 hours
Reported as:: Number · percent of participants

Percent of Subjects Who Are Free of Nausea at 2 Hours.
percent of participants	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo
Percent of Subjects Who Are Free of Nausea at 2 Hours.	70.6 (.863 to 2.522)	72.2 (.662 to 1.506)	66.4 (.856 to 2.549)

SecondaryPercent of Subjects Who Are Free of Phonophobia at 2 Hours.

Time frame:: 2 hours
Reported as:: Number · Percent of participants

Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
Percent of participants	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.	53.4 (.904 to 2.353)	60.9 (.630 to 1.334)	46.2 (.977 to 2.590)

SecondaryPercent of Subjects Who Are Free of Photophobia at 2 Hours.

Time frame:: 2 hours
Reported as:: Number · Percent of participants

Percent of Subjects Who Are Free of Photophobia at 2 Hours.
Percent of participants	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo
Percent of Subjects Who Are Free of Photophobia at 2 Hours.	48.6 (.888 to 2.327)	52.3 (.631 to 1.315)	40.8 (.980 to 2.542)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aspirin, Acetaminophen, and Caffeine	—	0/266 (0%)	8/266 (3%)
Sumatriptan (100 mg)	—	0/271 (0%)	14/271 (5.2%)
Placebo	—	0/133 (0%)	3/133 (2.3%)

Most frequent other events

Most frequent other events
Event	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo
NauseaGastrointestinal disorders	8/266	14/271	3/133

Baseline characteristics

Age Continuous
Age Continuous(years)	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo	Total
Mean	38 ± 11.4	37.8 ± 11.4	37.6 ± 11.5	37.8 ± 11.4

Sex: Female, Male
Sex: Female, Male(Participants)	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo	Total
Female	250	245	125	620
Male	49	59	24	132

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo	Total
American Indian or Alaska Native	1	1	0	2
Asian	3	9	5	17
Native Hawaiian or Other Pacific Islander	1	2	0	3
Black or African American	44	47	24	115
White	244	239	113	596
Other	6	6	7	19
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Aspirin, Acetaminophen, and Caffeine	Sumatriptan (100 mg)	Placebo	Total
United States	299	304	149	752

Study locations

20 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01248468
Lead sponsor: Novartis
Responsible party: Sponsor
First posted: Nov 25, 2010
Start date: Nov 2010
Primary completion: Mar 2011
Completion: Mar 2011
Results posted: Jul 30, 2012
Last update: Jul 30, 2012

Study contacts

Clinical Project Leader

study director · Novartis Consumer Health

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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