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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Aspirin, acetaminophen and caffeine; Drug: Sumatriptan

• Study Type: Interventional
• Enrollment (Actual): 752
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States
    • San Francisco, California, 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
  • Illinois
    • Chicago, Illinois, United States
  • Michigan
    • Ann Arbor, Michigan, United States
  • Missouri
    • Springfield, Missouri, United States
  • New York
    • Bronx, New York, United States
    • Rochester, New York, United States
  • North Carolina
    • Raleigh, North Carolina, United States
  • Ohio
    • Cleveland, Ohio, United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States
  • Tennessee
    • Nashville, Tennessee, United States
  • Texas
    • San Antonio, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Washington
    • Seattle, Washington, United States

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects Who Are Pain Free at 2 Hours.	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	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects Who Are Free of Nausea at 2 Hours.	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	2 hours
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.	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	2 hours
Percent of Subjects Who Are Free of Photophobia at 2 Hours.	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	2 hours

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Director: Clinical Project Leader, Novartis Consumer Health

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 24, 2010
• First Posted (ESTIMATE): November 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2012
• Last Update Submitted That Met QC Criteria: June 22, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Pain, Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; 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; Purinergic Antagonists; Purinergic Agents; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Vasoconstrictor Agents; Aspirin; Acetaminophen; Caffeine; Sumatriptan
• Other Study ID Numbers: 176-P-401