Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy

NCT ID: NCT00632385

Last Updated: 2021-01-27

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

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-08-31

Brief Summary

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To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Eletriptan

Intervention Type DRUG

40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred \>2 hours from first dose and within 24 hours of first dose

Interventions

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Eletriptan

40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred \>2 hours from first dose and within 24 hours of first dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year
* Eletriptan naive
* Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months

Exclusion Criteria

* Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
* Migraine attacks that are atypical or chronic daily headaches
* A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Irvine, California, United States

Site Status

Pfizer Investigational Site

Newport Beach, California, United States

Site Status

Pfizer Investigational Site

San Francisco, California, United States

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Pfizer Investigational Site

Plantation, Florida, United States

Site Status

Pfizer Investigational Site

St. Petersburg, Florida, United States

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Pfizer Investigational Site

Tampa, Florida, United States

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Pfizer Investigational Site

Marietta, Georgia, United States

Site Status

Pfizer Investigational Site

South Bend, Indiana, United States

Site Status

Pfizer Investigational Site

Milford, Massachusetts, United States

Site Status

Pfizer Investigational Site

Chesterfield, Missouri, United States

Site Status

Pfizer Investigational Site

Springfield, Missouri, United States

Site Status

Pfizer Investigational Site

Greensboro, North Carolina, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Eugene, Oregon, United States

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Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Alexandria, Virginia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A1601092

Identifier Type: -

Identifier Source: org_study_id

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