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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


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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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