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.
1 other identifier
interventional
752
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2010
Shorter than P25 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
July 30, 2012
CompletedJuly 30, 2012
June 1, 2012
4 months
November 23, 2010
March 22, 2012
June 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percent of Subjects Who Are Free of Nausea at 2 Hours.
2 hours
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
2 hours
Percent of Subjects Who Are Free of Photophobia at 2 Hours.
2 hours
Study Arms (3)
Aspirin, acetaminophen and caffeine
EXPERIMENTALAAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
Sumatriptan (100 mg)
ACTIVE COMPARATOR1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Placebo
PLACEBO COMPARATOR1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Interventions
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (20)
Unknown Facility
Anaheim, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Springfield, Missouri, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Leader
- Organization
- Novartis Consumer Health
Study Officials
- STUDY DIRECTOR
Clinical Project Leader
Novartis Consumer Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 25, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
July 30, 2012
Results First Posted
July 30, 2012
Record last verified: 2012-06