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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00174395
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 27, 2021
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine Drug: eletriptan Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Eletriptan

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174395


Locations
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Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
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
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Pfizer Investigational Site
Bathurst, New Brunswick, Canada
Pfizer Investigational Site
Moncton, 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
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
Canada, Prince Edward Island
Pfizer Investigational Site
Montague, Prince Edward Island, Canada
Canada, Quebec
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
Canada, Saskatchewan
Pfizer Investigational Site
Regina, Saskatchewan, Canada
Canada
Pfizer Investigational Site
Mount Pearl, Canada
Pfizer Investigational Site
Quebec, Canada
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00174395    
Other Study ID Numbers: A1601107
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Migraine Disorders
Pain
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurologic Manifestations
Eletriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs