Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine With or Without Aura
Intervention: Placebo (Drug); Eletriptan 40 mg (Drug); Eletriptan 80 mg (Drug); Sumatriptan 25 mg (Drug); Sumatriptan 50 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The objective of this study was to compare the efficacy, toleration and safety of eletriptan
40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects
with an acute migraine.
Clinical Details
Official title: A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Headache response at 1 hour after the first dose for the first attack.
Secondary outcome: Pain-free response at 1 hour after the first dose for the first attack.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects who expected to suffer at least one acute attack of migraine, with or
without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria
proposed by the International Headache Society (IHS))
- Subjects capable of taking medication as outpatients, and recording the effects of
such medication.
Exclusion Criteria:
- Pregnant or breast-feeding women
- Migraine subjects who also suffered from concomitant frequent (non-migrainous)
headache, defined as more than six attacks per month on average.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 1996
Last updated: November 11, 2013
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