Drug Use Investigation for IMIGRAN Tablet

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Sumatriptan

• Study Type: Observational
• Enrollment (Actual): 3571

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female Japanese subjects with migraine disorders who were considered appropriate to prescribe sumatriptan tablet according to the prescribing information were eligible for this surveillance study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects prescribed IMIGRAN; Subjects with migraine disorders prescribed IMIGRAN during study period	Drug: Sumatriptan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of incidence of adverse events in subjects with migraine disorders	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	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of arrhythmia	Occurrence of arrhythmia is investigated throughout study period.	2 months
Occurrence of angina pectoris	Occurrence of angina pectoris is investigated throughout study period.	2 months
Occurrence of myocardial infarction	Occurrence of myocardial infarction is investigated throughout study period.	2 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): February 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: March 3, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (Estimate): June 20, 2011

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Sumatriptan
• Other Study ID Numbers: 112324