Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo

NCT ID: NCT01986270

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1141 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-12-31

Study Completion Date

1998-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine With or Without Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Eletriptan 40 mg

Group Type EXPERIMENTAL

Eletriptan 40 mg

Intervention Type DRUG

40mg oral

Eletriptan 80 mg

Group Type EXPERIMENTAL

Eletriptan 80 mg

Intervention Type DRUG

80mg oral

Sumatriptan 25 mg

Group Type EXPERIMENTAL

Sumatriptan 25 mg

Intervention Type DRUG

25mg oral

Sumatriptan 50 mg

Group Type EXPERIMENTAL

Sumatriptan 50 mg

Intervention Type DRUG

50mg oral

Interventions

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Placebo

Matching Placebo

Intervention Type DRUG

Eletriptan 40 mg

40mg oral

Intervention Type DRUG

Eletriptan 80 mg

80mg oral

Intervention Type DRUG

Sumatriptan 25 mg

25mg oral

Intervention Type DRUG

Sumatriptan 50 mg

50mg oral

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A160-104

Identifier Type: -

Identifier Source: org_study_id

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