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

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ClinicalTrials.gov Identifier: NCT00174395
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 2, 2007
Sponsor:
Information provided by:
Pfizer

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 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 related topics: Migraine
U.S. FDA Resources




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


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Ages Eligible for Study:   18 Years to 65 Years   (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.

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


  Show 33 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00174395     History of Changes
Other Study ID Numbers: A1601107
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Migraine Disorders
Pain
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Eletriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs