Status:
COMPLETED
Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
Lead Sponsor:
Novartis
Conditions:
Pain, Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
- Inclusion criteria:
- Male or female aged 18 years and over.
- International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
- History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
- History of at least moderate migraine pain intensity, if left untreated.
- Exclusion criteria:
- 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)
- 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).
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
752 Patients enrolled
Trial Details
Trial ID
NCT01248468
Start Date
November 1 2010
End Date
March 1 2011
Last Update
July 30 2012
Active Locations (20)
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1
Anaheim, California, United States
2
San Francisco, California, United States
3
Clearwater, Florida, United States
4
DeLand, Florida, United States