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A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174395
First received: September 9, 2005
Last updated: October 31, 2007
Last verified: October 2007
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
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 (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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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: NCT00174395
Show 33 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174395
Show 33 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00174395 History of Changes |
| Other Study ID Numbers: |
A1601107 |
| Study First Received: | September 9, 2005 |
| Last Updated: | October 31, 2007 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Eletriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 18, 2017