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

Primary Purpose

Pain, Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aspirin, acetaminophen and caffeine
Sumatriptan
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Migraine focused on measuring Pain, Migraine

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.

Exclusion 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, 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)
  2. 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).
  3. 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Aspirin, acetaminophen and caffeine

Sumatriptan (100 mg)

Placebo

Arm Description

AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets

1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets

1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent of Subjects Who Are Free of Nausea at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Percent of Subjects Who Are Free of Photophobia at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours

Full Information

First Posted
November 23, 2010
Last Updated
June 22, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01248468
Brief Title
Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan 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 Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Migraine
Keywords
Pain, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
752 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin, acetaminophen and caffeine
Arm Type
Experimental
Arm Description
AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
Arm Title
Sumatriptan (100 mg)
Arm Type
Active Comparator
Arm Description
1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Intervention Type
Drug
Intervention Name(s)
Aspirin, acetaminophen and caffeine
Intervention Description
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
Intervention Type
Drug
Intervention Name(s)
Sumatriptan
Intervention Description
100 mg Sumatriptan
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Percent of Subjects Who Are Pain Free at 2 Hours.
Description
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
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Percent of Subjects Who Are Free of Nausea at 2 Hours.
Description
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Time Frame
2 hours
Title
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
Description
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Time Frame
2 hours
Title
Percent of Subjects Who Are Free of Photophobia at 2 Hours.
Description
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Leader
Organizational Affiliation
Novartis Consumer Health
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Deland
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Springfield
State/Province
Missouri
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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