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Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00632385
First received: March 3, 2008
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy
| Condition | Intervention | Phase |
|---|---|---|
| Migraine | Drug: Eletriptan | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline in headache pain severity [ Time Frame: 1, 2, 4, and 24 hours ]
Secondary Outcome Measures:
- Functional impairment [ Time Frame: 1, 2, 4, and 24 hours ]
- Work Productivity Questionnaire [ Time Frame: Week 10 ]
- Time Loss [ Time Frame: Week 10 ]
- Subject Preference Questionnaire [ Time Frame: Week 10 ]
- Global Evaluation [ Time Frame: Week 10 ]
- Subject Satisfaction Scale [ Time Frame: Week 10 ]
- Associated Symptoms [ Time Frame: 1, 2, 4, and 24 hours ]
- Use of Rescue Medication [ Time Frame: Week 10 ]
- Adverse events [ Time Frame: Week 10 ]
- Vital signs [ Time Frame: Week 10 ]
- Physical examination [ Time Frame: Week 10 ]
| Enrollment: | 127 |
| Study Start Date: | January 2003 |
| Study Completion Date: | August 2003 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Eletriptan
40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose
|
Eligibility| 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 headache according to International Headache Society criteria and migraine headaches for at least 1 year
- Eletriptan naive
- Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months
Exclusion Criteria:
- Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
- Migraine attacks that are atypical or chronic daily headaches
- A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632385
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632385
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Irvine, California, United States, 92618 | |
| Pfizer Investigational Site | |
| Newport Beach, California, United States, 92660-2452 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94109 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Plantation, Florida, United States, 33324 | |
| Pfizer Investigational Site | |
| St Petersburg, Florida, United States, 33710 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33609 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Marietta, Georgia, United States, 30067 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| South Bend, Indiana, United States, 46601 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Milford, Massachusetts, United States, 01757 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Chesterfield, Missouri, United States, 63017 | |
| Pfizer Investigational Site | |
| Springfield, Missouri, United States, 65804 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Greensboro, North Carolina, United States, 27403 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Alexandria, Virginia, United States, 22304 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
| ClinicalTrials.gov Identifier: | NCT00632385 History of Changes |
| Other Study ID Numbers: |
A1601092 |
| Study First Received: | March 3, 2008 |
| Last Updated: | April 22, 2011 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Rizatriptan |
Eletriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 18, 2017