Special Drug Use Investigation for AMERGE® Tablet (Long-term)

NCT ID: NCT01332383

Last Updated: 2015-08-13

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-10-31

Brief Summary

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To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting

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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Patients prescribed AMERGE

Patients with migraine disorders prescribed AMERGE during study period

Naratriptan

Intervention Type DRUG

Interventions

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Naratriptan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must use AMERGE for the first time

Exclusion Criteria

* Patients with hypersensitivity to naratriptan or any of the components.
* Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
* Patients with history of cerebral vascular disturbance or transient ischaemic attack
* Patients with peripheral vascular syndromes
* Patients with uncontrolled hypertension
* Patients with severe renal or hepatic impairment
* Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication
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

Other Identifiers

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112925

Identifier Type: -

Identifier Source: org_study_id

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