Drug Use Investigation for IMIGRAN Tablet

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

Total Enrollment

3571 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-09-30

Study Completion Date

2005-11-30

Brief Summary

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The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study.

A special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.

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Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects prescribed IMIGRAN

Subjects with migraine disorders prescribed IMIGRAN during study period

Sumatriptan

Intervention Type DRUG

Interventions

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Sumatriptan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with migraine disorders

Exclusion Criteria

* Subjects with hypersensitivity to sumatriptan
* Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
* Subjects with history of peripheral vascular disorder
* Subjects with history of cerebrovascular disorder or transient ischemic attacks
* Subjects with uncontrolled high-blood pressure
* Subjects with severe hepatic function disorder
* Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
* Subjects taking monoamine oxidaze inhibitor or use within 2 weeks of discontinuation

Eligible Sex

ALL

Accepts Healthy Volunteers

No