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

Tracking Information

First Received Date ^ICMJE

March 3, 2008

Last Updated Date

April 23, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline in headache pain severity [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00632385 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Functional impairment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
Work Productivity Questionnaire [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Time Loss [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Subject Preference Questionnaire [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Global Evaluation [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Subject Satisfaction Scale [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Associated Symptoms [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
Use of Rescue Medication [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: Eletriptan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

123

Completion Date

August 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00632385

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc

Study ID Numbers ^ICMJE

A1601092

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP