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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01973205
First received: October 25, 2013
Last updated: January 23, 2014
Last verified: January 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.


Estimated Enrollment: 900
Study Start Date: October 2013
Estimated Study Completion Date: July 2014
Estimated 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

Contacts
Contact: Novartis Clinical Project Leader 973-503-7812

Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, California
Recruiting
Anaheim, California, United States
Recruiting
San Francisco, California, United States
United States, Florida
Recruiting
Ft Lauderdale, Florida, United States
Recruiting
Jupiter, Florida, United States
Recruiting
Oviedo, Florida, United States
Recruiting
West Palm Beach, Florida, United States
United States, Indiana
Recruiting
Evansville, Indiana, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
United States, New Jersey
Recruiting
Berlin, New Jersey, United States
United States, New York
Recruiting
Bronx, New York, United States
Recruiting
Rochester, New York, United States
Recruiting
Williamsville, New York, United States
United States, North Carolina
Recruiting
Raleigh, North Carolina, United States
United States, Ohio
Recruiting
Cincinnati, Ohio, United States
Recruiting
Cleveland, Ohio, United States
United States, South Carolina
Recruiting
Mount Pleasant, South Carolina, United States
United States, Utah
Recruiting
Salt Lake City, Utah, United States
United States, Wisconsin
Recruiting
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: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Migraine
acetaminophen
aspirin

Additional relevant MeSH terms:
Headache Disorders, Primary
Headache Disorders
Migraine 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014