- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01973205
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
June 9, 2015 updated by: Novartis
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
The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
900
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
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California
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Anaheim, California, United States
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San Francisco, California, United States
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Florida
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Ft Lauderdale, Florida, United States
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Jupiter, Florida, United States
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Oviedo, Florida, United States
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West Palm Beach, Florida, United States
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Indiana
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Evansville, Indiana, United States
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Michigan
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Ann Arbor, Michigan, United States
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New Jersey
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Berlin, New Jersey, United States
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New York
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Bronx, New York, United States
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Rochester, New York, United States
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Williamsville, New York, United States
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North Carolina
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Raleigh, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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South Carolina
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Mount Pleasant, South Carolina, United States
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Utah
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Salt Lake City, Utah, United States
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Wisconsin
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Kenosha, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- 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:
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)
- History of vomiting during more than 20% of migraine attacks.
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
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2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
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Experimental: Acetaminophen 250 mg and aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
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2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Who Are Pain Free at the 2-hour Assessment
Time Frame: 2 hours
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Number of subjects who are pain free at the 2-hour assessment
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2 hours
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Number of Subjects Who Are Nausea Free at the 2-hour Assessment
Time Frame: 2 hours
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Number of subjects who are nausea free at the 2-hour assessment
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2 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
Time Frame: 2 hours
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Number of subjects who are free of photophobia at the 2-hour assessment.
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2 hours
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Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
Time Frame: 2 hours
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Number of subjects who are free of phonophobia at the 2-hour assessment.
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2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Project Lead, Novartis Consumer Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
October 25, 2013
First Submitted That Met QC Criteria
October 25, 2013
First Posted (Estimate)
October 31, 2013
Study Record Updates
Last Update Posted (Estimate)
June 11, 2015
Last Update Submitted That Met QC Criteria
June 9, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
- Acetaminophen
Other Study ID Numbers
- 863-P-303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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