Drug Use Investigation for IMIGRAN Tablet

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Sumatriptan

• Registration Number: NCT01376141
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2005-02
• Study Completion: 2005-11
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3571

Inclusion Criteria

• Subjects with migraine disorders

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed IMIGRAN	Sumatriptan	Subjects with migraine disorders prescribed IMIGRAN during study period

Primary Outcome Measures

Name	Time	Method
The number of incidence of adverse events in subjects with migraine disorders	2 months	Adverse event (AE), diagnosis or symptom, date of onset, outcome, date of outcome, seriousness, reason for judgement of "serious", intensity, relationship to IMIGRAN, other factors suspected to have relationship to AE

Secondary Outcome Measures

Name	Time	Method
Occurrence of angina pectoris	2 months	Occurrence of angina pectoris is investigated throughout study period.
Occurrence of arrhythmia	2 months	Occurrence of arrhythmia is investigated throughout study period.
Occurrence of myocardial infarction	2 months	Occurrence of myocardial infarction is investigated throughout study period.