Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

NCT ID: NCT01376193

Last Updated: 2013-05-20

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-10-31

Brief Summary

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The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects prescribed naratriptan tablets

Subjects with migraine headache prescribed naratriptan tablets during study period

Naratriptan

Intervention Type DRUG

Collection of safety data

Interventions

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Naratriptan

Collection of safety data

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with migraine headache
* Must use naratriptan tablets for the first time

Exclusion Criteria

* Subjects with hypersensitivity to naratriptan
* 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 or renal function disorder
* Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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Takao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.

Reference Type BACKGROUND

Other Identifiers

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112924

Identifier Type: -

Identifier Source: org_study_id

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