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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174395

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: eletriptan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Eletriptan Eletriptan Hydrobromide

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	220
Study Start Date:	March 2005
Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174395

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Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A1601107
Study First Received:	September 9, 2005
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00174395 History of Changes
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Eletriptan
Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on November 22, 2009