Clinical trial NCT00174395: A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Chilliwack
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Langley
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: North Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Penticton
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Bathurst
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Moncton
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Bolton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Corunna
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Fort Erie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Woodstock
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montague
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Cowansville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Drummondville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Granby
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sainte Julie
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Mount Pearl
country: Canada
facility: Pfizer Investigational Site
city: Quebec
country: Canada
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: