Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
NCT ID: NCT01248468
Last Updated: 2012-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
752 participants
INTERVENTIONAL
2010-11-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Aspirin, acetaminophen and caffeine
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
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
Sumatriptan
100 mg Sumatriptan
Placebo
1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Placebo
placebo
Interventions
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Aspirin, acetaminophen and caffeine
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
Sumatriptan
100 mg Sumatriptan
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
2. International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
3. History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
4. History of at least moderate migraine pain intensity, if left untreated.
Exclusion Criteria
* 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)
2. 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).
3. History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Project Leader
Role: STUDY_DIRECTOR
Novartis Consumer Health
Locations
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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
Rochester, New York, United States
The Bronx, New York, United States
Raleigh, North Carolina, United States
Cleveland, Ohio, United States
Mt. Pleasant, South Carolina, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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176-P-401
Identifier Type: -
Identifier Source: org_study_id