Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-Inflammatory Drugs - Tabular View

Tracking Information

First Received Date ^ICMJE

March 3, 2008

Last Updated Date

April 23, 2008

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Headache severity and response post-treatment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Functional response post-treatment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00634985 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
Migraine recurrence post-treatment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
Time loss (from normal activities and from work) post-treatment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Subject preference and acceptability post-treatment [ Time Frame: 24 hours and 12 weeks ] [ Designated as safety issue: No ]
Subject satisfaction post-treatment [ Time Frame: 2 and 24 hours ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Electrocardiogram [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Headache severity and response at baseline and post-treatment [ Time Frame: 1, 4 and 24 hours ] [ Designated as safety issue: No ]
Functional impairment severity and response at baseline and post-treatment [ Time Frame: 1, 4 and 24 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-Inflammatory Drugs

Official Title ^ICMJE

A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS

Brief Summary

To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)

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

106

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Met International Headache Society diagnostic criteria for migraine with or without aura
Expected to suffer one to six acute migraine attacks per month based on past history
Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs

Exclusion Criteria:

Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
Atypical migraines that consistently failed to respond to adequate medical therapy
Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT ID ^ICMJE

NCT00634985

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc

Study ID Numbers ^ICMJE

A1601085

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