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

Condition(s) targeted: Migraine

Intervention: eletriptan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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 outcome: 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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Pfizer Investigational Site, Mount Pearl, Canada

Pfizer Investigational Site, Quebec, Canada

Pfizer Investigational Site, Edmonton, Alberta, Canada

Pfizer Investigational Site, Chilliwack, British Columbia, Canada

Pfizer Investigational Site, Coquitlam, British Columbia, Canada

Pfizer Investigational Site, Langley, British Columbia, Canada

Pfizer Investigational Site, North Vancouver, British Columbia, Canada

Pfizer Investigational Site, Penticton, British Columbia, Canada

Pfizer Investigational Site, Winnipeg, Manitoba, Canada

Pfizer Investigational Site, Bathurst, New Brunswick, Canada

Pfizer Investigational Site, Moncton, New Brunswick, Canada

Pfizer Investigational Site, St. John's, Newfoundland and Labrador, Canada

Pfizer Investigational Site, Halifax, Nova Scotia, Canada

Pfizer Investigational Site, Truro, Nova Scotia, Canada

Pfizer Investigational Site, Bolton, Ontario, Canada

Pfizer Investigational Site, Brampton, Ontario, Canada

Pfizer Investigational Site, Corunna, Ontario, Canada

Pfizer Investigational Site, Fort Erie, Ontario, Canada

Pfizer Investigational Site, Hamilton, Ontario, Canada

Pfizer Investigational Site, London, Ontario, Canada

Pfizer Investigational Site, Markham, Ontario, Canada

Pfizer Investigational Site, Mississauga, Ontario, Canada

Pfizer Investigational Site, Newmarket, Ontario, Canada

Pfizer Investigational Site, Niagara Falls, Ontario, Canada

Pfizer Investigational Site, Woodstock, Ontario, Canada

Pfizer Investigational Site, Montague, Prince Edward Island, Canada

Pfizer Investigational Site, Cowansville, Quebec, Canada

Pfizer Investigational Site, Drummondville, Quebec, Canada

Pfizer Investigational Site, Granby, Quebec, Canada

Pfizer Investigational Site, Montreal, Quebec, Canada

Pfizer Investigational Site, Sainte Julie, Quebec, Canada

Pfizer Investigational Site, Sherbrooke, Quebec, Canada

Pfizer Investigational Site, Regina, Saskatchewan, Canada

To obtain contact information for a study center near you, click here.

Starting date: March 2005
Last updated: October 31, 2007