A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine

NCT ID: NCT00300924

Last Updated: 2008-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-01-31

Brief Summary

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The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rizatriptan co-administered with Acetaminophen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is at least 18 years of age
* Subject has at least a 6 month history of migraine, with or without aura
* Subject can distinguish between migraine attacks and other types of headaches
* Subject of childbearing potential agrees to use adequate contraception

Exclusion Criteria

* Subject typically has fewer than 1 or greater than 6 migraine attacks per month
* Subject typically has greater than 10 headache days per month
* Subject has evidence of ischemic heart disease
* Subject has uncontrolled high blood pressure
* Subject has a history, within 1 year, or current evidence of drug or alcohol abuse

\*This list is not all inclusive\*
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Diamond Headache Clinic

OTHER

Sponsor Role lead

Responsible Party

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Diamond Headache Clinic

Principal Investigators

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Merle Diamond, M.D.

Role: STUDY_DIRECTOR

Diamond Headache Clinic

Locations

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SanFrancisco Headache Clinic

San Francisco, California, United States

Site Status

Diamond Headache Clinic

Chicago, Illinois, United States

Site Status

Westside Family Medical Center

Kalamazoo, Michigan, United States

Site Status

Clinvest

Springfield, Missouri, United States

Site Status

Mercy Health Research

St Louis, Missouri, United States

Site Status

Elkind Headache Center

Mount Vernon, New York, United States

Site Status

ClinExcel

West Chester, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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Merk 075-00

Identifier Type: -

Identifier Source: secondary_id

Merck 075-00

Identifier Type: -

Identifier Source: org_study_id