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Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01248468
First received: November 23, 2010
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  Purpose

The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.


Condition Intervention Phase
Pain, Migraine
 Drug: Aspirin, acetaminophen and caffeine
Drug: Sumatriptan
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Parallel-group Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine.

Resource links provided by NLM:

MedlinePlus related topics: Caffeine Migraine
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percent of Subjects Who Are Pain Free at 2 Hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours


Secondary Outcome Measures:
  • Percent of Subjects Who Are Free of Nausea at 2 Hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours

  • Percent of Subjects Who Are Free of Phonophobia at 2 Hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours

  • Percent of Subjects Who Are Free of Photophobia at 2 Hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours


Enrollment: 752
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin, acetaminophen and caffeine
AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
 Drug: Aspirin, acetaminophen and caffeine
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
Active Comparator: Sumatriptan (100 mg)
1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
 Drug: Sumatriptan
100 mg Sumatriptan
Placebo Comparator: Placebo
1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
 Drug: Placebo
placebo

  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.

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, ophthalmoplegic 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. Routine use (≥ 10 days per month, on average) of any medication having the potential to interfere with the pharmacologic effects or evaluation of the study medications (e.g., narcotic and non-narcotic analgesic products (prescription or over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics, hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs).
  3. History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248468

Locations
United States, California
Anaheim, California, United States
San Francisco, California, United States
United States, Florida
Clearwater, Florida, United States
Deland, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
West Palm Beach, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Missouri
Springfield, Missouri, United States
United States, New York
Bronx, New York, United States
Rochester, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, South Carolina
Mount Pleasant, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Novartis
Investigators
Study Director: Clinical Project Leader Novartis Consumer Health
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01248468     History of Changes
Other Study ID Numbers: 176-P-401
Study First Received: November 23, 2010
Results First Received: March 22, 2012
Last Updated: June 22, 2012
Health Authority: United Stated: Aspire Institutional Review Board, LLC

Keywords provided by Novartis:
Pain, Migraine

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

ClinicalTrials.gov processed this record on May 21, 2013