Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
NCT ID: NCT01973205
Last Updated: 2015-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
900 participants
INTERVENTIONAL
2013-10-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Acetaminophen 250 mg and aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
Interventions
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Acetaminophen 250 mg and Aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
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.
5. History of frequently or always experiencing nausea with the migraine attack.
Exclusion Criteria
1. 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, opthalmoplegic 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. History of vomiting during more than 20% of migraine attacks.
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 Lead
Role: STUDY_DIRECTOR
Novartis Consumer Health
Locations
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Birmingham, Alabama, United States
Anaheim, California, United States
San Francisco, California, United States
Fort Lauderdale, Florida, United States
Jupiter, Florida, United States
Oviedo, Florida, United States
West Palm Beach, Florida, United States
Evansville, Indiana, United States
Ann Arbor, Michigan, United States
Berlin, New Jersey, United States
Rochester, New York, United States
The Bronx, New York, United States
Williamsville, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Mt. Pleasant, South Carolina, United States
Salt Lake City, Utah, United States
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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863-P-303
Identifier Type: -
Identifier Source: org_study_id
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