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

Primary Purpose

Acute Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen 250 mg and Aspirin 250 mg
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Migraine focused on measuring Migraine, acetaminophen, aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Acetaminophen 250 mg and aspirin 250 mg

Arm Description

2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets

2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg

Outcomes

Primary Outcome Measures

Number of Subjects Who Are Pain Free at the 2-hour Assessment
Number of subjects who are pain free at the 2-hour assessment
Number of Subjects Who Are Nausea Free at the 2-hour Assessment
Number of subjects who are nausea free at the 2-hour assessment

Secondary Outcome Measures

Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
Number of subjects who are free of photophobia at the 2-hour assessment.
Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
Number of subjects who are free of phonophobia at the 2-hour assessment.

Full Information

First Posted
October 25, 2013
Last Updated
June 9, 2015
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01973205
Brief Title
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo 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 a Combination of Acetaminophen and Aspirin vs Placebo in the Acute Treatment of Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine
Keywords
Migraine, acetaminophen, aspirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Arm Title
Acetaminophen 250 mg and aspirin 250 mg
Arm Type
Experimental
Arm Description
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Intervention Type
Drug
Intervention Name(s)
Acetaminophen 250 mg and Aspirin 250 mg
Intervention Description
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Primary Outcome Measure Information:
Title
Number of Subjects Who Are Pain Free at the 2-hour Assessment
Description
Number of subjects who are pain free at the 2-hour assessment
Time Frame
2 hours
Title
Number of Subjects Who Are Nausea Free at the 2-hour Assessment
Description
Number of subjects who are nausea free at the 2-hour assessment
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
Description
Number of subjects who are free of photophobia at the 2-hour assessment.
Time Frame
2 hours
Title
Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
Description
Number of subjects who are free of phonophobia at the 2-hour assessment.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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: 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) History of vomiting during more than 20% of migraine attacks. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Lead
Organizational Affiliation
Novartis Consumer Health
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Ft Lauderdale
State/Province
Florida
Country
United States
City
Jupiter
State/Province
Florida
Country
United States
City
Oviedo
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Berlin
State/Province
New Jersey
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Williamsville
State/Province
New York
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Kenosha
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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