Drug Use Investigation for IMIGRAN Tablet

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Migraine Disorders

Treatments: Drug: Sumatriptan

Study type: Observational

Funder types: Industry

Identifiers

NCT01376141

112324

Details and patient eligibility

About

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.

Enrollment: 3,571 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,571 participants in 1 patient group

Subjects prescribed IMIGRAN

Description:

Subjects with migraine disorders prescribed IMIGRAN during study period

Treatment:

Drug: Sumatriptan