Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine

June 9, 2015 updated by: Novartis

A Multi-center, Randomized, Double-blind, Parallel-group, Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of a Combination of Acetaminophen and Aspirin vs Placebo in the Acute Treatment of Migraine

The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Anaheim, California, United States
      • San Francisco, California, United States
    • Florida
      • Ft Lauderdale, Florida, United States
      • Jupiter, Florida, United States
      • Oviedo, Florida, United States
      • West Palm Beach, Florida, United States
    • Indiana
      • Evansville, Indiana, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • New Jersey
      • Berlin, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • Rochester, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • South Carolina
      • Mount Pleasant, South Carolina, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Wisconsin
      • Kenosha, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  5. History of frequently or always experiencing nausea with the migraine attack.

Exclusion criteria:

Subjects eligible for inclusion in this study must not fulfill any of the following 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, opthalmoplegic 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. History of vomiting during more than 20% of migraine attacks.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Drug: Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Experimental: Acetaminophen 250 mg and aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Drug: Acetaminophen 250 mg and Aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Are Pain Free at the 2-hour Assessment
Time Frame: 2 hours
Number of subjects who are pain free at the 2-hour assessment
2 hours
Number of Subjects Who Are Nausea Free at the 2-hour Assessment
Time Frame: 2 hours
Number of subjects who are nausea free at the 2-hour assessment
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
Time Frame: 2 hours
Number of subjects who are free of photophobia at the 2-hour assessment.
2 hours
Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
Time Frame: 2 hours
Number of subjects who are free of phonophobia at the 2-hour assessment.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Clinical Project Lead, Novartis Consumer Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (Estimate)

October 31, 2013

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 863-P-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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