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NCT00174395 Clinical Trial

A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine

Migraine Clinical Trial

Official title:
A Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00174395
Other study ID # A1601107
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2005
Est. completion date October 2006

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosis of migraine with or without aura according to the recent IHS criteria. - Migraine headaches must have been present for more than one year. - History in the last 3 months of 1 to 4 acute attacks of migraine headache per month. Exclusion Criteria: - Subjects with current or past history of coronary artery disease. - Pregnant or breastfeeding women. - Subjects who have chronic daily headaches.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• eletriptan

Locations
Country Name City State
Canada Pfizer Investigational Site Bathurst New Brunswick
Canada Pfizer Investigational Site Bolton Ontario
Canada Pfizer Investigational Site Brampton Ontario
Canada Pfizer Investigational Site Chilliwack British Columbia
Canada Pfizer Investigational Site Coquitlam British Columbia
Canada Pfizer Investigational Site Corunna Ontario
Canada Pfizer Investigational Site Cowansville Quebec
Canada Pfizer Investigational Site Drummondville Quebec
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Fort Erie Ontario
Canada Pfizer Investigational Site Granby Quebec
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Hamilton Ontario
Canada Pfizer Investigational Site Langley British Columbia
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Markham Ontario
Canada Pfizer Investigational Site Mississauga Ontario
Canada Pfizer Investigational Site Moncton New Brunswick
Canada Pfizer Investigational Site Montague Prince Edward Island
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Mount Pearl
Canada Pfizer Investigational Site Newmarket Ontario
Canada Pfizer Investigational Site Niagara Falls Ontario
Canada Pfizer Investigational Site North Vancouver British Columbia
Canada Pfizer Investigational Site Penticton British Columbia
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Regina Saskatchewan
Canada Pfizer Investigational Site Sainte Julie Quebec
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site St. John's Newfoundland and Labrador
Canada Pfizer Investigational Site Truro Nova Scotia
Canada Pfizer Investigational Site Winnipeg Manitoba
Canada Pfizer Investigational Site Woodstock Ontario

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.
Secondary To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence
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