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

NCT01248468 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 752

Last updated 2012-07-30

Study results available
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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.

Conditions

  • Pain, Migraine

Interventions

DRUG

Aspirin, acetaminophen and caffeine

2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)

DRUG

Sumatriptan

100 mg Sumatriptan

DRUG

Placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Clinical Project Leader · Novartis Consumer Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01248468 on ClinicalTrials.gov