Clinical trial NCT01248468: Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Migraine
Keywords: Pain, Migraine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-25
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percent of Subjects Who Are Pain Free at 2 Hours.
timeFrame: 2 hours
Secondary outcomes:
measure: Percent of Subjects Who Are Free of Nausea at 2 Hours.
timeFrame: 2 hours
measure: Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
timeFrame: 2 hours
measure: Percent of Subjects Who Are Free of Photophobia at 2 Hours.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Ann Arbor
country: United States
state: Michigan
city: Springfield
country: United States
state: Missouri
city: Bronx
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Mount Pleasant
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Novartis Consumer Health
name: Clinical Project Leader
role: STUDY_DIRECTOR
References: