Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00634985
First received: March 3, 2008
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: eletriptan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Headache severity and response post-treatment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Functional response post-treatment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
- Migraine recurrence post-treatment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
- Time loss (from normal activities and from work) post-treatment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Subject preference and acceptability post-treatment [ Time Frame: 24 hours and 12 weeks ] [ Designated as safety issue: No ]
- Subject satisfaction post-treatment [ Time Frame: 2 and 24 hours ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Physical examination [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Electrocardiogram [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Headache severity and response at baseline and post-treatment [ Time Frame: 1, 4 and 24 hours ] [ Designated as safety issue: No ]
- Functional impairment severity and response at baseline and post-treatment [ Time Frame: 1, 4 and 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | November 2002 |
| Study Completion Date: | December 2003 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: eletriptan
40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Met International Headache Society diagnostic criteria for migraine with or without aura
- Expected to suffer one to six acute migraine attacks per month based on past history
- Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs
Exclusion Criteria:
- Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
- Atypical migraines that consistently failed to respond to adequate medical therapy
- Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634985
Locations
| Turkey | |
| Pfizer Investigational Site | |
| Unknown, Ankara, Turkey | |
| Pfizer Investigational Site | |
| Capa, Istanbul, Turkey | |
| Pfizer Investigational Site | |
| Unknown, Manisa, Turkey | |
| Pfizer Investigational Site | |
| Gaziantep, Turkey | |
| Pfizer Investigational Site | |
| Istanbul, Turkey | |
| Pfizer Investigational Site | |
| Izmir, Turkey | |
| Pfizer Investigational Site | |
| Samsun, Turkey | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
| ClinicalTrials.gov Identifier: | NCT00634985 History of Changes |
| Other Study ID Numbers: | A1601085 |
| Study First Received: | March 3, 2008 |
| Last Updated: | April 22, 2011 |
| Health Authority: | Turkey: Ministry of Health, Central Ethics Committee |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Eletriptan Therapeutic Uses Pharmacologic Actions |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013