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Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01973205
Recruitment Status : Completed
First Posted : October 31, 2013
Results First Posted : June 11, 2015
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine

Condition or disease Intervention/treatment Phase
Acute Migraine Drug: Acetaminophen 250 mg and Aspirin 250 mg Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Parallel-group, Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of a Combination of Acetaminophen and Aspirin vs Placebo in the Acute Treatment of Migraine
Study Start Date : October 2013
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Drug: Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Experimental: Acetaminophen 250 mg and aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Drug: Acetaminophen 250 mg and Aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg


Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects Who Are Pain Free at the 2-hour Assessment [ Time Frame: 2 hours ]
    Number of subjects who are pain free at the 2-hour assessment

  2. Number of Subjects Who Are Nausea Free at the 2-hour Assessment [ Time Frame: 2 hours ]
    Number of subjects who are nausea free at the 2-hour assessment


Secondary Outcome Measures :
  1. Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. [ Time Frame: 2 hours ]
    Number of subjects who are free of photophobia at the 2-hour assessment.

  2. Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. [ Time Frame: 2 hours ]
    Number of subjects who are free of phonophobia at the 2-hour assessment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male or female aged 18 years and over.
  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:

Subjects eligible for inclusion in this study must not fulfill any of the following 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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973205


Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Anaheim, California, United States
San Francisco, California, United States
United States, Florida
Ft Lauderdale, Florida, United States
Jupiter, Florida, United States
Oviedo, Florida, United States
West Palm Beach, Florida, United States
United States, Indiana
Evansville, Indiana, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, New Jersey
Berlin, New Jersey, United States
United States, New York
Bronx, New York, United States
Rochester, New York, United States
Williamsville, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
United States, South Carolina
Mount Pleasant, South Carolina, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Wisconsin
Kenosha, Wisconsin, United States
Sponsors and Collaborators
Novartis
Investigators
Study Director: Clinical Project Lead Novartis Consumer Health
More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01973205     History of Changes
Other Study ID Numbers: 863-P-303
First Posted: October 31, 2013    Key Record Dates
Results First Posted: June 11, 2015
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by Novartis:
Migraine
acetaminophen
aspirin

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics