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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01973205
First received: October 25, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Acute Migraine
Drug: Acetaminophen 250 mg and Aspirin 250 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percent of subjects who are pain free at the 2-hour assessment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Percent of subjects who are pain free at the 2-hour assessment

  • Percent of subjects who are nausea free at the 2-hour assessment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Percent of subjects who are nausea free at the 2-hour assessment


Secondary Outcome Measures:
  • Percent of subjects who are free of photophobia at the 2-hour assessment. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Percent of subjects who are free of photophobia at the 2-hour assessment.

  • Percent of subjects who are free of phonophobia at the 2-hour assessment. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Percent of subjects who are free of phonophobia at the 2-hour assessment.


Enrollment: 900
Study Start Date: October 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01973205     History of Changes
Other Study ID Numbers: 863-P-303
Study First Received: October 25, 2013
Last Updated: September 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Migraine
acetaminophen
aspirin

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

ClinicalTrials.gov processed this record on October 20, 2014